Akorn, Inc.: Gentamicin Sulfate Ophthalmic Solution Recalled for Potential Impurities

Agency Publication Date: April 30, 2019

Summary

Akorn Animal Health is recalling approximately 52,350 bottles of Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, a veterinary antibiotic eye drop used for animals. The recall was initiated because stability testing at 9 and 18 months identified both individual and total impurities that exceeded approved limits (Out of Specification). These impurities can affect the quality and potentially the safety of the medication. Owners of animals using this medication should contact their veterinarian or pharmacist immediately.

Risk

The presence of impurities at levels higher than allowed could reduce the effectiveness of the antibiotic or cause unexpected adverse reactions or irritation in the eyes of treated animals. While specific injuries were not reported in this data, the failure to meet stability standards means the product's safety profile cannot be guaranteed.

What You Should Do

Check your animal's medication for Gentamicin Sulfate Ophthalmic Solution, USP, Sterile 0.3%, packaged in 5 mL dropper bottles with NDC 59399-101-05.
Verify the lot number and expiration date on the bottle or box: specifically look for Lot 7M11A with an expiration date of 11/2019.
If your product matches this lot and expiration date, stop using it on your animal immediately.
Contact your veterinarian or pharmacist for guidance on alternative treatments and to report the use of the affected product.
Return any unused product to the pharmacy or place of purchase for a refund and contact Akorn Animal Health for further instructions.
For additional questions, contact the FDA Consumer Complaint Coordinator in your state or call the FDA at 1-888-INFO-FDA.

Your Remedy Options

Full Refund

Pharmaceutical product return and refund

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

Affected Products

Product: Gentamicin Sulfate Ophthalmic Solution, USP, Sterile 0.3%, Veterinary (5 mL)

Model:

NDC: 59399-101-05

ANADA #200-576

Lot Numbers:

7M11A (Exp. 11/2019)

Date Ranges: Exp. 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82202

Status: Resolved

Manufacturer: Akorn, Inc.

Sold By: Veterinary clinics; Pharmacies

Manufactured In: United States

Units Affected: 52,350 bottles. 144 per case.

Distributed To: Nationwide

Agency Last Updated: May 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 · Raw API Response

Summary

Risk

What You Should Do

Check your animal's medication for Gentamicin Sulfate Ophthalmic Solution, USP, Sterile 0.3%, packaged in 5 mL dropper bottles with NDC 59399-101-05.

Verify the lot number and expiration date on the bottle or box: specifically look for Lot 7M11A with an expiration date of 11/2019.

If your product matches this lot and expiration date, stop using it on your animal immediately.

Contact your veterinarian or pharmacist for guidance on alternative treatments and to report the use of the affected product.

Return any unused product to the pharmacy or place of purchase for a refund and contact Akorn Animal Health for further instructions.

For additional questions, contact the FDA Consumer Complaint Coordinator in your state or call the FDA at 1-888-INFO-FDA.