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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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Low RiskFDA Vet
Pets & Animals/Pet Medications

Akorn Ophthalmic Ointment Recalled for Potential Foreign Material Exposure

Agency Publication Date: November 5, 2021
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Summary

Akorn, Inc. has voluntarily recalled 34,152 tubes of its Neomycin, Polymyxin B, and Bacitracin Zinc Ophthalmic Ointment, a sterile antibiotic treatment for animals. The recall was initiated because the product may have been exposed to foreign material during the filling process. No injuries or incidents have been reported to date, but the presence of foreign matter in an eye medication could cause irritation or injury to a treated animal.

Risk

The ointment may contain foreign particles introduced during manufacturing, which could cause physical irritation, inflammation, or infection when applied to an animal's eye. There have been no reported injuries related to this issue.

What You Should Do

  1. Check your product packaging for Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment (3.5 Gram metal tube) with NDC 57399-135-35 and lot number 0D25A.
  2. If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP
Variants: 3.5 Grams (1/8 oz.) Metal Tube, Sterile Ophthalmic Ointment, Rx only, For Veterinary Use Only
Model:
ANADA 200-553
Lot Numbers:
0D25A
NDC:
57399-135-35

Recall #: V-0024-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88977
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: Veterinary clinics; Pharmaceutical distributors
Manufactured In: United States
Units Affected: 34,152 tubes
Distributed To: Nationwide
Agency Last Updated: November 24, 2021

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