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Low RiskFDA Vet
Pets & Animals/Pet Medications

Nora Apothecary and Alternative Therapies, Inc.: Sterile Compounded Ophthalmic Medications Recalled for Sterility Concerns

Agency Publication Date: May 20, 2013
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Summary

Nora Apothecary and Alternative Therapies, Inc. is recalling 20 units of various sterile compounded veterinary medications, including Cyclosporine, EDTA, Tacrolimus, and Idoxuridine ophthalmic solutions and ointments. These products are being recalled because an FDA inspection revealed concerns with the pharmacy's quality control processes that could lead to a lack of sterility assurance. The recall includes all sterile drugs compounded and dispensed by the pharmacy on or before April 19, 2013, that have not yet reached their expiration date. Consumers who have these products should stop using them on their animals immediately and contact their veterinarian.

Risk

The lack of sterility assurance means these eye medications could be contaminated with microorganisms, which poses a serious risk of infection or other complications when applied to an animal's eyes.

What You Should Do

  1. Check your animal's medication packaging for the following products: Cyclosporine Opth Oint 0.2%, Cyclosporine Opth Soln (0.2%, 1%, or 2%), EDTA Opth Soln 1%, Tacrolimus Opth Soln (0.01% or 0.02%), or Idoxuridine Opth Soln 0.1%.
  2. Identify if the medication was compounded and dispensed by Nora Apothecary on or before Friday, April 19, 2013, and ensure the product is still within its listed 30-day expiration date.
  3. Immediately stop using the recalled ophthalmic product on your pet or animal.
  4. Contact your veterinarian or healthcare provider to discuss alternative treatments and to report any adverse health signs observed in the animal.
  5. Return any unused product to the pharmacy for a refund and contact Nora Apothecary at 1101 E 86th St, Indianapolis, IN 46240 for further instructions.
  6. For additional questions or to report issues, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug product refund and guidance

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

Affected Products

Product: Cyclosporine Opth Oint 0.2% (3 gm, 6 gm)
Model:
Recall #: V-183-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: Cyclosporine Opth Oint 0.2% (6 gm)
Model:
Recall #: V-184-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: Cyclosporine Opth Soln 0.2% (10 ml)
Model:
Recall #: V-185-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: Cyclosporine Opth Soln 1% (10 ml)
Model:
Recall #: V-186-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: Cyclosporine Opth Soln 2% (10 ml)
Model:
Recall #: V-187-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: EDTA Opth Soln 1% (10 ml)
Model:
Recall #: V-188-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: Tacrolimus Opth Soln 0.01% (10 ml)
Model:
Recall #: V-189-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: Tacrolimus Opth Soln 0.02% (10 ml)
Model:
Recall #: V-190-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013
Product: Idoxuridine Opth Soln 0.1% (5 ml)
Model:
Recall #: V-191-2013
Date Ranges: 30 day expiration, Dispensed on or before April 19, 2013

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 65020
Status: Resolved
Manufacturer: Nora Apothecary and Alternative Therapies, Inc.
Sold By: Nora Apothecary and Alternative Therapies, Inc.
Manufactured In: United States
Units Affected: 8 products (3; 2; 5; 4; 2; 1; 2; 1)
Distributed To: Indiana, Ohio, Illinois, Florida, Tennessee

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