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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83427

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

Open FDA event record

Event summary

Timeline bucket
July 24, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Colonia Care Pharmacy

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

32 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 32

C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0003-2020
Recall number
D-0003-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
2 droptainer bottles

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: product sterility cannot be guaranteed.

Code information

Lot #: a) 070819A, BUD 08/22/19; b) 071619F, BUD 08/30/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 2 of 32

C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0004-2020
Recall number
D-0004-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 droptainer bottle

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: product sterility cannot be guaranteed.

Code information

Lot #: 071819E, BUD 09/01/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 3 of 32

C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0005-2020
Recall number
D-0005-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
12 droptainer bottles

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: product sterility cannot be guaranteed.

Code information

Lot #: 070119A, BUD 08/15/19; 072219N, BUD 09/05/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 4 of 32

C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0006-2020
Recall number
D-0006-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 droptainer bottles

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: product sterility cannot be guaranteed.

Code information

Lot #: 071619D, BUD 08/30/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 5 of 32

C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0007-2020
Recall number
D-0007-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 071119C, BUD 08/25/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 6 of 32

C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0008-2020
Recall number
D-0008-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
60 nebulizer vials

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: product sterility cannot be guaranteed.

Code information

Lot #: 070219B, BUD 08/06/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 7 of 32

C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0009-2020
Recall number
D-0009-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
37 vials

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: product sterility cannot be guaranteed.

Code information

Lot #: 070319G, BUD 08/17/19; 071219P, BUD 08/26/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 8 of 32

C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0010-2020
Recall number
D-0010-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 droptainer vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 072219B, BUD 08/05/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 9 of 32

C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0011-2020
Recall number
D-0011-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 070319J, BUD 08/17/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 10 of 32

C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0012-2020
Recall number
D-0012-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
30 syringe

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: product sterility cannot be guaranteed.

Code information

Lot #: 062619E, BUD 08/10/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 11 of 32

C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0013-2020
Recall number
D-0013-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
15 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: product sterility cannot be guaranteed.

Code information

Lot #: 070919E, BUD 08/23/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 12 of 32

C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0014-2020
Recall number
D-0014-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
18 vials

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: product sterility cannot be guaranteed.

Code information

Lot #: 041119A, BUD 10/08/19; 051019J, BUD 11/6/19; 070519C, BUD 01/01/20

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 13 of 32

C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0015-2020
Recall number
D-0015-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 droptainer bottle

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: product sterility cannot be guaranteed.

Code information

Lot #: 070819B, BUD 08/07/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 14 of 32

C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0016-2020
Recall number
D-0016-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
6 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: product sterility cannot be guaranteed.

Code information

Lot #: 071819C, BUD 09/01/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 15 of 32

C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0017-2020
Recall number
D-0017-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
15 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: product sterility cannot be guaranteed.

Code information

Lot #: 070919C, BUD 08/23/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 16 of 32

C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0018-2020
Recall number
D-0018-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
191 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: product sterility cannot be guaranteed.

Code information

Lot #: 020719A, BUD 08/06/19; 051619E, BUD 11/12/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 17 of 32

C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0019-2020
Recall number
D-0019-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
6 vials

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: product sterility cannot be guaranteed.

Code information

Lot #: a) and b) 071119E, BUD 08/25/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 18 of 32

C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0020-2020
Recall number
D-0020-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 071619J, BUD 08/30/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 19 of 32

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0021-2020
Recall number
D-0021-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
2 vials

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: product sterility cannot be guaranteed.

Code information

Lot #: 072419C, BUD 09/07/19; 071519D, BUD 08/29/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 20 of 32

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0022-2020
Recall number
D-0022-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 071519E, BUD 08/29/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 21 of 32

C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0023-2020
Recall number
D-0023-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 062719E, BUD 08/11/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 22 of 32

C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0024-2020
Recall number
D-0024-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
7 vials

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: product sterility cannot be guaranteed.

Code information

Lot #: a) and b) 070519A, BUD 08/19/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 23 of 32

C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0025-2020
Recall number
D-0025-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 072219A, BUD 09/05/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 24 of 32

C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0026-2020
Recall number
D-0026-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 071819H, BUD 09/01/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 25 of 32

C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0027-2020
Recall number
D-0027-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 062419C, BUD 08/08/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 26 of 32

C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0028-2020
Recall number
D-0028-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 062419B, BUD 08/08/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 27 of 32

C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0029-2020
Recall number
D-0029-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 072419B, BUD 09/07/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 28 of 32

C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0030-2020
Recall number
D-0030-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 070319A, BUD 08/17/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 29 of 32

C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0031-2020
Recall number
D-0031-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 070319F, BUD 08/17/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 30 of 32

C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0032-2020
Recall number
D-0032-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 droptainer bottle

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: product sterility cannot be guaranteed.

Code information

Lot #: 071019B, BUD 08/09/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 31 of 32

C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0033-2020
Recall number
D-0033-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
7 vials

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: product sterility cannot be guaranteed.

Code information

Lot #: 062719A, BUD 08/11/19

Distribution pattern

Patient Specific Prescriptions in NJ

drug · product 32 of 32

C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

D-0034-2020
Recall number
D-0034-2020
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Colonia Care Pharmacy
Quantity
1 vial

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: product sterility cannot be guaranteed.

Code information

Lot #: 072319A, BUD 09/06/19

Distribution pattern

Patient Specific Prescriptions in NJ