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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84546

118 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 20, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Assurance Infusion

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

118 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 118

Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800

D-0662-2020
Recall number
D-0662-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
60 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 09262019@13 Exp. 03/24/2020; 10072019@03/04/2020; 12062019@2 Exp. 06/03/2020; 12172019@12 Exp. 01/31/2020; 08142019@20 Exp. 02/10/2020

Distribution pattern

Nationwide within the United States

drug · product 2 of 118

Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800

D-0663-2020
Recall number
D-0663-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
32 droppers

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12092019@33 Exp. 03/08/2020; 11112019@30 Exp. 02/09/2020; 10012019@17 Exp. 12/30/2019; 10162019@18 Exp. 01/14/2020; 10252019@11 Exp. 01/23/2020

Distribution pattern

Nationwide within the United States

drug · product 3 of 118

BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800

D-0664-2020
Recall number
D-0664-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12172019@2 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 4 of 118

BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0665-2020
Recall number
D-0665-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@23 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 5 of 118

BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0666-2020
Recall number
D-0666-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@20 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 6 of 118

BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0667-2020
Recall number
D-0667-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12102019@8 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 7 of 118

BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0668-2020
Recall number
D-0668-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12172019@3 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 8 of 118

BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0669-2020
Recall number
D-0669-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@7 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 9 of 118

BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0670-2020
Recall number
D-0670-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12102019@2 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 10 of 118

BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0671-2020
Recall number
D-0671-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12172019@6 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 11 of 118

BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0672-2020
Recall number
D-0672-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@16 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 12 of 118

BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0673-2020
Recall number
D-0673-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12202019@2 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 13 of 118

BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0674-2020
Recall number
D-0674-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@27 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 14 of 118

BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0675-2020
Recall number
D-0675-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@2 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 15 of 118

BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0676-2020
Recall number
D-0676-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@18 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 16 of 118

Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

D-0677-2020
Recall number
D-0677-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
15 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 09192019@19 Exp. 03/17/2020; 08162019@5 Exp. 02/12/2020

Distribution pattern

Nationwide within the United States

drug · product 17 of 118

Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

D-0678-2020
Recall number
D-0678-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 07302019@15 Exp. 01/29/2020

Distribution pattern

Nationwide within the United States

drug · product 18 of 118

BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800

D-0679-2020
Recall number
D-0679-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
28 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 11132019@15 Exp. 02/11/2020; 12112019@25 Exp. 02/13/2020; 11202019@9 Exp. 02/13/2020

Distribution pattern

Nationwide within the United States

drug · product 19 of 118

BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0680-2020
Recall number
D-0680-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@29 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 20 of 118

BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0681-2020
Recall number
D-0681-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@8 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 21 of 118

BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0682-2020
Recall number
D-0682-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@4 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 22 of 118

BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0683-2020
Recall number
D-0683-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@6 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 23 of 118

BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0684-2020
Recall number
D-0684-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12132019@5 Exp. 12/22/2019

Distribution pattern

Nationwide within the United States

drug · product 24 of 118

BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0685-2020
Recall number
D-0685-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12182019@2 Exp. 12/27/2019

Distribution pattern

Nationwide within the United States

drug · product 25 of 118

BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0686-2020
Recall number
D-0686-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@20 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 26 of 118

BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0687-2020
Recall number
D-0687-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@25 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 27 of 118

BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0688-2020
Recall number
D-0688-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@10 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 28 of 118

BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0689-2020
Recall number
D-0689-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@4 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 29 of 118

BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

D-0690-2020
Recall number
D-0690-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12102019@3 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 30 of 118

BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0691-2020
Recall number
D-0691-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12172019@5 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 31 of 118

BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0692-2020
Recall number
D-0692-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@28 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 32 of 118

BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0693-2020
Recall number
D-0693-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12172019@10 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 33 of 118

BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0694-2020
Recall number
D-0694-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@8 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 34 of 118

BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0695-2020
Recall number
D-0695-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12182019@1 Exp. 12/27/2019

Distribution pattern

Nationwide within the United States

drug · product 35 of 118

BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0696-2020
Recall number
D-0696-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@15 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 36 of 118

BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0697-2020
Recall number
D-0697-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@10 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 37 of 118

BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0698-2020
Recall number
D-0698-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@27 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 38 of 118

BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0699-2020
Recall number
D-0699-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12132019@3 Exp. 12/22/2019

Distribution pattern

Nationwide within the United States

drug · product 39 of 118

BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0700-2020
Recall number
D-0700-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@23 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 40 of 118

BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0701-2020
Recall number
D-0701-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@11 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 41 of 118

BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0702-2020
Recall number
D-0702-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12202019@1 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 42 of 118

BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

D-0703-2020
Recall number
D-0703-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@17 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 43 of 118

BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0704-2020
Recall number
D-0704-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@18 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 44 of 118

BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0705-2020
Recall number
D-0705-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@1 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 45 of 118

BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800

D-0706-2020
Recall number
D-0706-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12162019@28 Exp. 12/25/2019; 12102019@1 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 46 of 118

BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0707-2020
Recall number
D-0707-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12102019@4 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 47 of 118

BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0708-2020
Recall number
D-0708-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12102019@5 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 48 of 118

BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0709-2020
Recall number
D-0709-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12172019@4 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 49 of 118

BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0710-2020
Recall number
D-0710-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12182019@7 Exp. 12/27/2019

Distribution pattern

Nationwide within the United States

drug · product 50 of 118

BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0711-2020
Recall number
D-0711-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12112019@5 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 51 of 118

BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0712-2020
Recall number
D-0712-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12102019@6 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 52 of 118

BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0713-2020
Recall number
D-0713-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12122019@26 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 53 of 118

BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0714-2020
Recall number
D-0714-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12122019@21 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 54 of 118

BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0715-2020
Recall number
D-0715-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12162019@6 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 55 of 118

BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0716-2020
Recall number
D-0716-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12122019@12 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 56 of 118

BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0717-2020
Recall number
D-0717-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12182019@4 Exp. 12/27/2019

Distribution pattern

Nationwide within the United States

drug · product 57 of 118

BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0718-2020
Recall number
D-0718-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12122019@5 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 58 of 118

BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0719-2020
Recall number
D-0719-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12172019@13 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 59 of 118

CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800

D-0720-2020
Recall number
D-0720-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
19 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 08212019@29 Exp. 02/17/2020; 07152019@12 Exp. 01/11/2020; 07082019@26 Exp. 01/04/2020;

Distribution pattern

Nationwide within the United States

drug · product 60 of 118

CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0721-2020
Recall number
D-0721-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@24 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 61 of 118

CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0722-2020
Recall number
D-0722-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12132019@8 Exp. 12/22/2019

Distribution pattern

Nationwide within the United States

drug · product 62 of 118

CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0723-2020
Recall number
D-0723-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@22 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 63 of 118

CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

D-0724-2020
Recall number
D-0724-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@21 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 64 of 118

CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0725-2020
Recall number
D-0725-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@15 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 65 of 118

FENT 600MCG/ SUF 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0726-2020
Recall number
D-0726-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@8 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 66 of 118

FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0727-2020
Recall number
D-0727-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@3 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 67 of 118

FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0728-2020
Recall number
D-0728-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12122019@18 Exp. 12/21/2019; 12162019@24 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 68 of 118

FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0729-2020
Recall number
D-0729-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12182019@3 Exp. 12/27/2019

Distribution pattern

Nationwide within the United States

drug · product 69 of 118

FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0730-2020
Recall number
D-0730-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@11 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 70 of 118

FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0731-2020
Recall number
D-0731-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@30 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 71 of 118

FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0732-2020
Recall number
D-0732-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@14 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 72 of 118

FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0733-2020
Recall number
D-0733-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12132019@1 Exp. 12/22/2019

Distribution pattern

Nationwide within the United States

drug · product 73 of 118

HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800

D-0734-2020
Recall number
D-0734-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 11252019@27 Exp. 12/29/2019; 11272019@30 Exp. 12/31/2019; 12112019@16 Exp. 01/14/2020; 12062019@7 Exp. 01/09/2020

Distribution pattern

Nationwide within the United States

drug · product 74 of 118

HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800

D-0735-2020
Recall number
D-0735-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12162019@38 Exp. 01/16/2020; 11272019@32 Exp. 12/31/2019

Distribution pattern

Nationwide within the United States

drug · product 75 of 118

HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800

D-0736-2020
Recall number
D-0736-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 11272019@31 Exp. 12/31/2019; 12022019@19 Exp. 01/05/2020

Distribution pattern

Nationwide within the United States

drug · product 76 of 118

HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0737-2020
Recall number
D-0737-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@4 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 77 of 118

HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0738-2020
Recall number
D-0738-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@12 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 78 of 118

HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0739-2020
Recall number
D-0739-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@3 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 79 of 118

HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0740-2020
Recall number
D-0740-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@7 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 80 of 118

HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0741-2020
Recall number
D-0741-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@9 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 81 of 118

HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0742-2020
Recall number
D-0742-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@17 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 82 of 118

HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0743-2020
Recall number
D-0743-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
4 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12112019@1 Exp. 12/20/2019; 12112019@6 Exp. 12/20/2019; 12162019@23 Exp. 12/25/2019; 12172019@7 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 83 of 118

HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0744-2020
Recall number
D-0744-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12162019@14 Exp. 12/25/2019; 12102019@19 Exp. 12/19/2019

Distribution pattern

Nationwide within the United States

drug · product 84 of 118

HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0745-2020
Recall number
D-0745-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12182019@6 Exp. 12/27/2019

Distribution pattern

Nationwide within the United States

drug · product 85 of 118

HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0746-2020
Recall number
D-0746-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12132019@4 Exp. 12/22/2019

Distribution pattern

Nationwide within the United States

drug · product 86 of 118

HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0747-2020
Recall number
D-0747-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12132019@9 Exp. 12/22/2019

Distribution pattern

Nationwide within the United States

drug · product 87 of 118

IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800

D-0748-2020
Recall number
D-0748-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 07162019@20 Exp. 01/12/2020; 12102019@17 Exp. 06/07/2020; 07162019@20 Exp. 01/12/2020

Distribution pattern

Nationwide within the United States

drug · product 88 of 118

LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800

D-0749-2020
Recall number
D-0749-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes/1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 09172019@18 Exp. 03/15/2020

Distribution pattern

Nationwide within the United States

drug · product 89 of 118

MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0750-2020
Recall number
D-0750-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@9 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 90 of 118

MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0751-2020
Recall number
D-0751-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
4 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@13 Exp. 12/21/2019; 12172019@9 Exp. 12/26/2019; 12122019@10 Exp. 12/21/2019; 12162019@13 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 91 of 118

MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0752-2020
Recall number
D-0752-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@19 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 92 of 118

MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0753-2020
Recall number
D-0753-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@30 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 93 of 118

MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0754-2020
Recall number
D-0754-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@31 Exp. 12/21/2019; 12172019@8 Exp. 12/26/2019

Distribution pattern

Nationwide within the United States

drug · product 94 of 118

MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0755-2020
Recall number
D-0755-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
3 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12102019@7 Exp. 12/19/2019; 12112019@11 Exp. 12/20/2019; 12162019@5 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 95 of 118

MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0756-2020
Recall number
D-0756-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@20 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 96 of 118

MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0757-2020
Recall number
D-0757-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12132019@6 Exp. 12/22/2019; 12182019@5 Exp. 12/27/2019

Distribution pattern

Nationwide within the United States

drug · product 97 of 118

MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800

D-0758-2020
Recall number
D-0758-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
3 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12112019@24 Exp. 12/20/2019; 12122019@1 Exp. 12/21/2019; 12122019@2 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 98 of 118

MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0759-2020
Recall number
D-0759-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 12122019@7 Exp. 12/21/2019; 12162019@27 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 99 of 118

MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0760-2020
Recall number
D-0760-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@19 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 100 of 118

MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0761-2020
Recall number
D-0761-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12112019@21 Exp. 12/20/2019

Distribution pattern

Nationwide within the United States

drug · product 101 of 118

PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800

D-0762-2020
Recall number
D-0762-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
2 syringes

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 10142019@14 Exp. 01/12/2020; 11042019@8 Exp. 02/02/2020

Distribution pattern

Nationwide within the United States

drug · product 102 of 118

QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800

D-0763-2020
Recall number
D-0763-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 07012019@30 Exp. 12/28/2019

Distribution pattern

Nationwide within the United States

drug · product 103 of 118

QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0764-2020
Recall number
D-0764-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
190 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 07012019@30 Exp. 12/28/2019; 08052019@13 Exp. 02/01/2020; 09252019@15 Exp. 03/23/2020; 10292019@12 Exp. 04/26/2020; 10092019@6 Exp. 03/04/2020; 10162019@12 Exp. 04/13/2020; 12042019@31 Exp. 01/18/2020; 12162019@35 Exp. 01/30/2020; 11262019@37 Exp. 05/24/2020

Distribution pattern

Nationwide within the United States

drug · product 104 of 118

QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800

D-0765-2020
Recall number
D-0765-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 08132019@15 Exp. 02/09/2020

Distribution pattern

Nationwide within the United States

drug · product 105 of 118

QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0766-2020
Recall number
D-0766-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
134 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 07222019@10 Exp. 01/18/2020; 06242019@19 Exp. 12/21/2019; 08132019@15 Exp. 02/09/2020; 10292019@22 Exp. 04/26/2020; 11272019@24 Exp. 01/22/2020; 09182019@18 Exp. 03/16/2020

Distribution pattern

Nationwide within the United States

drug · product 106 of 118

SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0767-2020
Recall number
D-0767-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@26 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 107 of 118

SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800

D-0768-2020
Recall number
D-0768-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12162019@9 Exp. 12/25/2019

Distribution pattern

Nationwide within the United States

drug · product 108 of 118

SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800

D-0769-2020
Recall number
D-0769-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 syringe

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 12122019@19 Exp. 12/21/2019

Distribution pattern

Nationwide within the United States

drug · product 109 of 118

TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800

D-0770-2020
Recall number
D-0770-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
5 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 10242019@7 Exp. 04/21/2020; 10032019@11 Exp. 03/31/2020; 11042019@12 Exp. 05/02/2020; 09242019@9 Exp. 03/22/2020

Distribution pattern

Nationwide within the United States

drug · product 110 of 118

TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800

D-0771-2020
Recall number
D-0771-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
7 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 08212019@17 Exp. 02/17/2020; 10232019@23 Exp. 04/20/2020

Distribution pattern

Nationwide within the United States

drug · product 111 of 118

TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800

D-0772-2020
Recall number
D-0772-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
166 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020

Distribution pattern

Nationwide within the United States

drug · product 112 of 118

TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800

D-0773-2020
Recall number
D-0773-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1290 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 07082019@29 Exp. 01/04/2020; 06252019@11 Exp. 12/22/2019; 07082019@29 Exp. 01/04/2020; 06252019@6 Exp. 12/22/2019; 07082019@28 Exp. 01/04/2020; 07262019@3 Exp. 01/22/2020; 07102019@13 Exp. 01/06/2020; 07162019@13 Exp. 01/12/2020; 07242019@15 Exp. 01/20/2020; 07162019@12 Exp. 01/12/2020; 08272019@11 Exp. 02/23/2020; 08162019@6 Exp. 02/12/2020; 07312019@14 Exp. 01/27/2020; 07262019@4 Exp. 01/22/2020; 08152019@9 Exp. 02/11/2020; 08162019@6 Exp. 02/12/2020; 08092019@6 Exp. 02/05/2020; 07312019@15 Exp. 01/27/2020; 08092019@5 Exp. 02/05/2020; 08272019@12 Exp. 02/23/2020; 09032019@36 Exp. 03/01/2020; 10012019@19 Exp. 03/30/2020; 09162019@15 Exp. 03/14/2020; 09162019@14 Exp. 03/14/2020; 09032019@35 Exp. 03/01/2020; 09032019@35 Exp. 03/01/2020; 09242019@15 Exp. 03/22/2020; 09112019@5 Exp. 03/09/2020; 10022019@15 Exp. 03/30/2020; 09112019@4 Exp. 03/09/2020; 10162019@16 Exp. 04/13/2020; 10282019@21 Exp. 04/25/2020; 10212019@20 Exp. 03/04/2020; 10162019@15 Exp. 04/13/2020; 10282019@22 Exp. 04/25/2020; 10242019@6 Exp. 03/04/2020; 10232019@25 Exp. 03/04/2020 Exp. 10082019@4 Exp. 04/05/2020; 10082019@5 Exp. 04/05/2020; 11262019@26 Exp. 01/10/2020; 12032019@12 Exp. 01/17/2020; 11262019@25 Exp. 01/10/2020; 10302019@24 Exp. 04/27/2020; 11262019@27 Exp. 01/10/2020; 10302019@23 Exp. 04/27/2020; 12032019@11 Exp. 01/17/2020; 11042019@10 Exp. 03/04/2020; 11042019@10 Exp. 03/04/2020; 11262019@24 Exp. 01/10/2020; 12042019@14 Exp. 01/18/2020; 12042019@15 Exp. 01/18/2020; 12102019@14 Exp. 01/24/2020; 12102019@13 Exp. 01/24/2020

Distribution pattern

Nationwide within the United States

drug · product 113 of 118

TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0774-2020
Recall number
D-0774-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
1 vial

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 11042019@28 Exp. 05/02/2020

Distribution pattern

Nationwide within the United States

drug · product 114 of 118

TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0775-2020
Recall number
D-0775-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
10 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 07082019@31 Exp. 01/04/2020

Distribution pattern

Nationwide within the United States

drug · product 115 of 118

TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0776-2020
Recall number
D-0776-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
358 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 08082019@7 Exp. 02/04/2020; 08232019@1 Exp. 02/19/2020; 07262019@12 Exp. 01/22/2020; 07012019@25 Exp. 12/28/2019; 07102019@14 Exp. 01/06/2020; 09202019@4 Exp. 03/18/2020; 10282019@23 Exp. 04/25/2020; 10092019@7 Exp. 03/04/2020; 08292019@11 Exp. 02/25/2020; 10042019@6 Exp. 04/01/2020; 10162019@20 Exp. 04/13/2020; 11062019@24 Exp. 03/04/2020; 12042019@20 Exp. 01/18/2020; 12102019@11 Exp. 01/24/2020; 12162019@36 Exp. 01/30/2020; 11262019@29 Exp. 01/10/2020

Distribution pattern

Nationwide within the United States

drug · product 116 of 118

TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0777-2020
Recall number
D-0777-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
10 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lot: 08302019@4 Exp. 02/26/2020

Distribution pattern

Nationwide within the United States

drug · product 117 of 118

TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0778-2020
Recall number
D-0778-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
20 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 07032019@12 Exp. 12/30/2019; 08212019@32 Exp. 02/17/2020; 10032019@12 Exp. 03/31/2020

Distribution pattern

Nationwide within the United States

drug · product 118 of 118

TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0779-2020
Recall number
D-0779-2020
Initiated
December 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Assurance Infusion
Quantity
45 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

Lots: 10152019@23 Exp. 03/04/2020; 10302019@27 Exp. 04/27/2020; 08052019@19 Exp. 02/01/2020; 10032019@14 Exp. 03/31/2020

Distribution pattern

Nationwide within the United States