Medications & Supplements/Prescription Drugs

Colonia Care Pharmacy: Sterile Injectable and Ophthalmic Medications Recalled for Lack of Sterility

Agency Publication Date: October 1, 2019

Summary

Colonia Care Pharmacy is recalling 426 units of various compounded medications, including eye drops (Ophthalmic), injections, and inhalation solutions, because they may not be sterile. The recall includes products such as C-Acetylcysteine, C-Atropine Sulf, and C-Methylcobalamin, which were provided as patient-specific prescriptions. Using a non-sterile medication intended for injection, inhalation, or the eyes can lead to serious infections and health complications. Consumers who have these medications should contact their healthcare provider or pharmacist immediately for guidance and to arrange for a refund.

Risk

The medications were produced without sufficient assurance of sterility, meaning they may be contaminated with bacteria or other microorganisms. If non-sterile products are injected into the body or applied to the eyes, they can cause severe infections that may be difficult to treat or lead to permanent damage.

What You Should Do

Check your medication labels for 'Colonia Care Pharmacy' and the specific product name to see if it is affected by this recall.
Verify the Lot Number and Beyond Use Date (BUD) on your product. Affected lots include C-Atropine Sulf (Lot 070119A, BUD 08/15/19), C-Methylcobalamin (Lot 020719A, BUD 08/06/19), and C-Hydroxyprogesterone Capro (Lot 041119A, BUD 10/08/19), among many others listed in the product details.
Immediately stop using any of the recalled medications if you find a matching lot number.
Contact your healthcare provider or pharmacist for guidance on alternative treatments and to report any adverse effects.
Return any unused medication to Colonia Care Pharmacy at 515 Inman Ave., Suite A, Colonia, N.J. 07067, for a refund.
Contact the manufacturer at 732-381-1133 for further instructions regarding this recall.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

Full Refund

Patient refund and pharmacist guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: C-ACETYLCYSTEINE OPHTH 10% SOLN (5 mL and 10 mL)

Lot Numbers:

070819A (BUD 08/22/19)

071619F (BUD 08/30/19)

Product: C-ALBUMIN 5% OPHTH SOLUTION (10 mL)

Lot Numbers:

071819E (BUD 09/01/19)

Product: C-ATROPINE SULF OPHTH 0.01% (5 mL)

Lot Numbers:

070119A (BUD 08/15/19)

072219N (BUD 09/05/19)

Product: C-ATROPINE SULF OPHTH 0.02% (5 mL)

Lot Numbers:

071619D (BUD 08/30/19)

Product: C-CALCIUM GLUCNATE 1% INJECTION SOLN (10 mL)

Lot Numbers:

071119C (BUD 08/25/19)

Product: C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION (120 mL)

Lot Numbers:

070219B (BUD 08/06/19)

Product: C-DEXAMETHASONE 24MG/ML INJ SOLUTION (1 mL)

Lot Numbers:

070319G (BUD 08/17/19)

071219P (BUD 08/26/19)

Product: C-EDETATE DISODIUM 1.5% OPHTH SOLUTION (10 mL)

Lot Numbers:

072219B (BUD 08/05/19)

Product: C-GENTAMICIN 30MG/ML INJ SOLUTION SDV (3 mL)

Lot Numbers:

070319J (BUD 08/17/19)

Product: C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION (1 mL syringe)

Lot Numbers:

062619E (BUD 08/10/19)

Product: C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION (1 mL syringe)

Lot Numbers:

070919E (BUD 08/23/19)

Product: C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION (5 mL)

Lot Numbers:

041119A (BUD 10/08/19)

051019J (BUD 11/6/19)

070519C (BUD 01/01/20)

Product: C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION (3 mL)

Lot Numbers:

070819B (BUD 08/07/19)

Product: C-MB12/HB12 5MG/5MG/ML INJ SOLN (0.9 mL syringe)

Lot Numbers:

071819C (BUD 09/01/19)

Product: C-MB12 NAC 13MG/48MG/ML INJ SOLN (0.29 mL syringe)

Lot Numbers:

070919C (BUD 08/23/19)

Product: C-METHYLCOBALAMIN 25MG/ML INJECTION PFS (0.3 mL, 0.5 mL, 1 mL, 3 mL syringes)

Lot Numbers:

020719A (BUD 08/06/19)

051619E (BUD 11/12/19)

Product: C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML (5 mL and 10 mL)

Lot Numbers:

071119E (BUD 08/25/19)

Product: C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML (5 mL)

Lot Numbers:

071619J (BUD 08/30/19)

Product: C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML (5 mL)

Lot Numbers:

072419C (BUD 09/07/19)

071519D (BUD 08/29/19)

Product: C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML (5 mL)

Lot Numbers:

071519E (BUD 08/29/19)

Product: C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML (10 mL)

Lot Numbers:

062719E (BUD 08/11/19)

Product: C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML (5 mL and 10 mL)

Lot Numbers:

070519A (BUD 08/19/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML (5 mL)

Lot Numbers:

072219A (BUD 09/05/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML (5 mL)

Lot Numbers:

071819H (BUD 09/01/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML (5 mL)

Lot Numbers:

062419C (BUD 08/08/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML (5 mL)

Lot Numbers:

062419B (BUD 08/08/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML (5 mL)

Lot Numbers:

072419B (BUD 09/07/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML (5 mL)

Lot Numbers:

070319A (BUD 08/17/19)

Product: C-PHENOL/COTTONSEED OIL INJ 5% (5 mL)

Lot Numbers:

070319F (BUD 08/17/19)

Product: C-TACROLIMUS 0.03% OPHTHAL SUSPENSION (5 mL)

Lot Numbers:

071019B (BUD 08/09/19)

Product: C-UREA 40% BLADDER INSTILL (30 mL)

Lot Numbers:

062719A (BUD 08/11/19)

Product: C-VERAPAMIL 2.5MG/ML INJ SOLN (10 mL)

Lot Numbers:

072319A (BUD 09/06/19)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83427

Status: Resolved

Manufacturer: Colonia Care Pharmacy

Sold By: Colonia Care Pharmacy

Manufactured In: United States

Units Affected: 32 products (2 droptainer bottles; 1 droptainer bottle; 12 droptainer bottles; 1 droptainer bottles; 1 vial; 60 nebulizer vials; 37 vials; 1 droptainer vial; 1 vial; 30 syringe; 15 syringes; 18 vials; 1 droptainer bottle; 6 syringes; 15 syringes; 191 syringes; 6 vials; 1 vial; 2 vials; 1 vial; 1 vial; 7 vials; 1 vial; 1 vial; 1 vial; 1 vial; 1 vial; 1 vial; 1 vial; 1 droptainer bottle; 7 vials; 1 vial)

Distributed To: New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication labels for 'Colonia Care Pharmacy' and the specific product name to see if it is affected by this recall.

Verify the Lot Number and Beyond Use Date (BUD) on your product. Affected lots include C-Atropine Sulf (Lot 070119A, BUD 08/15/19), C-Methylcobalamin (Lot 020719A, BUD 08/06/19), and C-Hydroxyprogesterone Capro (Lot 041119A, BUD 10/08/19), among many others listed in the product details.

Immediately stop using any of the recalled medications if you find a matching lot number.

Contact your healthcare provider or pharmacist for guidance on alternative treatments and to report any adverse effects.

Return any unused medication to Colonia Care Pharmacy at 515 Inman Ave., Suite A, Colonia, N.J. 07067, for a refund.

Contact the manufacturer at 732-381-1133 for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332.

Affected Products

Product: C-ACETYLCYSTEINE OPHTH 10% SOLN (5 mL and 10 mL)

Lot Numbers:

070819A (BUD 08/22/19)

071619F (BUD 08/30/19)

Product: C-ALBUMIN 5% OPHTH SOLUTION (10 mL)

Lot Numbers:

071819E (BUD 09/01/19)

Product: C-ATROPINE SULF OPHTH 0.01% (5 mL)

Lot Numbers:

070119A (BUD 08/15/19)

072219N (BUD 09/05/19)

Product: C-ATROPINE SULF OPHTH 0.02% (5 mL)

Lot Numbers:

071619D (BUD 08/30/19)

Product: C-CALCIUM GLUCNATE 1% INJECTION SOLN (10 mL)

Lot Numbers:

071119C (BUD 08/25/19)

Product: C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION (120 mL)

Lot Numbers:

070219B (BUD 08/06/19)

Product: C-DEXAMETHASONE 24MG/ML INJ SOLUTION (1 mL)

Lot Numbers:

070319G (BUD 08/17/19)

071219P (BUD 08/26/19)

Product: C-EDETATE DISODIUM 1.5% OPHTH SOLUTION (10 mL)

Lot Numbers:

072219B (BUD 08/05/19)

Product: C-GENTAMICIN 30MG/ML INJ SOLUTION SDV (3 mL)

Lot Numbers:

070319J (BUD 08/17/19)

Product: C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION (1 mL syringe)

Lot Numbers:

062619E (BUD 08/10/19)

Product: C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION (1 mL syringe)

Lot Numbers:

070919E (BUD 08/23/19)

Product: C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION (5 mL)

Lot Numbers:

041119A (BUD 10/08/19)

051019J (BUD 11/6/19)

070519C (BUD 01/01/20)

Product: C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION (3 mL)

Lot Numbers:

070819B (BUD 08/07/19)

Product: C-MB12/HB12 5MG/5MG/ML INJ SOLN (0.9 mL syringe)

Lot Numbers:

071819C (BUD 09/01/19)

Product: C-MB12 NAC 13MG/48MG/ML INJ SOLN (0.29 mL syringe)

Lot Numbers:

070919C (BUD 08/23/19)

Product: C-METHYLCOBALAMIN 25MG/ML INJECTION PFS (0.3 mL, 0.5 mL, 1 mL, 3 mL syringes)

Lot Numbers:

020719A (BUD 08/06/19)

051619E (BUD 11/12/19)

Product: C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML (5 mL and 10 mL)

Lot Numbers:

071119E (BUD 08/25/19)

Product: C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML (5 mL)

Lot Numbers:

071619J (BUD 08/30/19)

Product: C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML (5 mL)

Lot Numbers:

072419C (BUD 09/07/19)

071519D (BUD 08/29/19)

Product: C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML (5 mL)

Lot Numbers:

071519E (BUD 08/29/19)

Product: C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML (10 mL)

Lot Numbers:

062719E (BUD 08/11/19)

Product: C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML (5 mL and 10 mL)

Lot Numbers:

070519A (BUD 08/19/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML (5 mL)

Lot Numbers:

072219A (BUD 09/05/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML (5 mL)

Lot Numbers:

071819H (BUD 09/01/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML (5 mL)

Lot Numbers:

062419C (BUD 08/08/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML (5 mL)

Lot Numbers:

062419B (BUD 08/08/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML (5 mL)

Lot Numbers:

072419B (BUD 09/07/19)

Product: C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML (5 mL)

Lot Numbers:

070319A (BUD 08/17/19)

Product: C-PHENOL/COTTONSEED OIL INJ 5% (5 mL)

Lot Numbers:

070319F (BUD 08/17/19)

Product: C-TACROLIMUS 0.03% OPHTHAL SUSPENSION (5 mL)

Lot Numbers:

071019B (BUD 08/09/19)

Product: C-UREA 40% BLADDER INSTILL (30 mL)

Lot Numbers:

062719A (BUD 08/11/19)

Product: C-VERAPAMIL 2.5MG/ML INJ SOLN (10 mL)

Lot Numbers:

072319A (BUD 09/06/19)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83427

Status: Resolved

Manufacturer: Colonia Care Pharmacy

Sold By: Colonia Care Pharmacy

Manufactured In: United States

Distributed To: New Jersey