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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82398

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

Open FDA event record

Event summary

Timeline bucket
March 13, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Advanced Pharma Inc.

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

19 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 19

HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1016-2019
Recall number
D-1016-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
2400 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 12/03/18 4090 28967S Exp. 4/2/2019; 12/03/18 6221 28967S Exp. 4/2/2019

Distribution pattern

Nationwide

drug · product 2 of 19

fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1017-2019
Recall number
D-1017-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
360 bags

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 01/03/19 1311 21010P Exp. 5/3/2019

Distribution pattern

Nationwide

drug · product 3 of 19

fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1018-2019
Recall number
D-1018-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
180 bags

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 01/03/19 1645 21025P Exp. 5/3/2019

Distribution pattern

Nationwide

drug · product 4 of 19

Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1019-2019
Recall number
D-1019-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
1125 bags

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 12/03/18 9479 40105P Exp. 4/2/2019; 12/3/18 6583 40105P Exp. 4/2/2019; 12/3/18 8918 40105P Exp. 4/2/2019; 12/03/18 4727 40105P Exp. 4/2/2019

Distribution pattern

Nationwide

drug · product 5 of 19

Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1020-2019
Recall number
D-1020-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
16075 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 01/18/19 3261 83067S Exp. 6/17/2019; 10/18/18 0212 83067S Exp. 3/17/2019; 10/23/18 7704 83067S Exp. 3/22/2019; 11/02/18 5909 83067S Exp. 4/1/2019; 10/31/18 8995 83067S Exp. 3/30/2019; 10/22/18 2570 83067S Exp. 3/21/2019; 10/18/18 6471 83067S Exp. 3/17/2019; 11/05/18 5527 83067S Exp. 4/4/2019; 11/05/18 0985 83067S Exp. 4/4/2019; 10/22/18 9234 83067S Exp. 3/21/2019; 10/30/18 6678 83067S Exp. 3/29/2019

Distribution pattern

Nationwide

drug · product 6 of 19

Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1021-2019
Recall number
D-1021-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
2580 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 12/05/18 0710 82867S Exp. 5/4/2019; 10/24/18 0014 82867S Exp. 3/23/2019; 11/01/18 8800 82867S Exp. 3/31/2019

Distribution pattern

Nationwide

drug · product 7 of 19

Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1022-2019
Recall number
D-1022-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
1575 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 10/18/18 1430 87661S Exp. 3/17/2019; 10/29/18 1805 87661S Exp. 3/28/2019

Distribution pattern

Nationwide

drug · product 8 of 19

Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1023-2019
Recall number
D-1023-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
22900 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 10/24/18 3318 83061S Exp. 3/23/2019; 10/18/18 3354 83061S Exp. 3/17/2019; 10/23/2018 6050 83061S Exp. 3/22/2019; 10/23/18 8105 83061S Exp. 3/22/2019; 10/18/18 1961 83061S Exp. 3/17/2019; 10/18/18 2598 83061S Exp. 3/17/2019; 11/05/18 1184 83061S Exp. 4/4/2019; 10/22/18 0737 83061S Exp. 3/21/2019; 10/25/18 1198 83061S Exp. 3/24/2019; 11/06/18 4451 83061S Exp. 4/5/2019; 11/06/18 0108 83061S Exp. 4/5/2019; 10/22/18 1530 83061S Exp. 3/21/2019

Distribution pattern

Nationwide

drug · product 9 of 19

Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1024-2019
Recall number
D-1024-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
5700 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 11/02/18 9350 82967S Exp. 4/1/2019; 10/23/18 1471 82967S Exp. 3/22/2019; 10/24/18 4412 82967S Exp. 3/23/2019; 10/24/18 0733 82967S Exp. 3/22/2019

Distribution pattern

Nationwide

drug · product 10 of 19

Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1025-2019
Recall number
D-1025-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
140 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 10/31/18 2288 82822S Exp. 3/30/2019; 10/18/18 8371 82822S Exp. 3/17/2019

Distribution pattern

Nationwide

drug · product 11 of 19

2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1026-2019
Recall number
D-1026-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
1540 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 10/18/18 2217 01122S Exp. 3/17/2019

Distribution pattern

Nationwide

drug · product 12 of 19

2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1027-2019
Recall number
D-1027-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
1980 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 10/19/18 1990 01167S Exp. 3/18/2019

Distribution pattern

Nationwide

drug · product 13 of 19

Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1028-2019
Recall number
D-1028-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
800 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 10/17/18 2976 86561S Exp. 3/16/2019

Distribution pattern

Nationwide

drug · product 14 of 19

Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1029-2019
Recall number
D-1029-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
550 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 11/06/18 5007 82761S Exp. 4/5/2019

Distribution pattern

Nationwide

drug · product 15 of 19

Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1030-2019
Recall number
D-1030-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
500 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 10/23/18 1998 72561SPF Exp. 3/22/2019

Distribution pattern

Nationwide

drug · product 16 of 19

Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1031-2019
Recall number
D-1031-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
1440 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 10/25/18 4819 73967S Exp. 3/24/2019

Distribution pattern

Nationwide

drug · product 17 of 19

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1032-2019
Recall number
D-1032-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
1850 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 11/01/18 8847 80261S Exp. 3/31/2019

Distribution pattern

Nationwide

drug · product 18 of 19

Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1033-2019
Recall number
D-1033-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
2325 syringes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots: 10/19/18 2117 24163M Exp. 3/18/2019; 11/5/18 1363 24163M Exp. 4/4/2019; 11/5/18 1511 24163M Exp. 4/4/2019; 10/19/18 2061 24163M Exp. 3/18/2019; 10/23/18 1963 14163M Exp. 3/22/2019; 10/19/18 1441 24163M Exp. 3/18/2019

Distribution pattern

Nationwide

drug · product 19 of 19

Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

D-1034-2019
Recall number
D-1034-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Advanced Pharma Inc.
Quantity
975

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot: 11/05/18 7020 88261S, exp 4/4/2019

Distribution pattern

Nationwide