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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Pets & Animals/Pet Medications

Colonia Care Pharmacy: Ophthalmic Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: October 10, 2019
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Summary

Colonia Care Pharmacy is recalling six total units of Tacrolimus and Cyclosporine ophthalmic (eye) drops because they cannot guarantee the products are sterile. Using non-sterile eye drops can lead to serious eye infections or other health complications for the pets receiving these patient-specific prescriptions. These products were distributed in droptainer bottles of various sizes (5 mL, 10 mL, and 15 mL) and were dispensed as individual prescriptions.

Risk

If an eye medication is not sterile, it may contain harmful bacteria or fungi that, when applied to the eye, can cause severe infections, inflammation, or permanent vision damage. No injuries or adverse events have been reported to date, but the lack of sterility assurance makes these products unsafe for use.

What You Should Do

  1. Check your prescription bottle label for the following product names and lot numbers: Tacrolimus Opthalmic 0.03% (Lot 070891C or 071719I), Cyclosporine Ophthalmic 2% 15 mL (Lot 053019D), or Cyclosporine Ophthalmic 2% 10 mL (Lot 071519B).
  2. Immediately stop using these eye drops on your pet if they match the recalled lot numbers.
  3. Contact your veterinarian or healthcare provider to discuss alternative treatments and to report any signs of infection in your pet.
  4. Return any unused portion of the medication to Colonia Care Pharmacy for a refund and contact them at 515 Inman Ave Ste A, Colonia, New Jersey for further instructions.
  5. For additional questions, you can contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund for patient-specific prescriptions

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

Affected Products

Product: Tacrolimus Opthalmic 0.03% (5 mL)
Model:
V-0051-2020
Lot Numbers:
070891C
071719I
Product: Cyclosporine Ophthalmic 2% (15 mL)
Model:
V-0052-2020
Lot Numbers:
053019D
Product: Cyclosporine Ophthalmic 2% (10 mL)
Model:
V-0053-2020
Lot Numbers:
071519B

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83772
Status: Active
Manufacturer: Colonia Care Pharmacy
Sold By: Colonia Care Pharmacy
Manufactured In: United States
Units Affected: 3 products (2 units; 3 units; 1 unit)
Distributed To: New Jersey
Agency Last Updated: October 16, 2019

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 ยท Raw API Response