Bimeda, Inc.: Griseofulvin Powder Recalled for Impurities and High Acid Content

Agency Publication Date: September 7, 2018

Summary

Bimeda, Inc. is recalling approximately 10,050 pouches of Griseofulvin Powder (microsize) for oral use in horses. This recall was initiated because laboratory testing found that the medication contained levels of Griseofulvic Acid and a single unknown impurity that exceeded safety and quality specifications. Consumers should contact their veterinarian or pharmacist immediately regarding this medication.

Risk

The presence of impurities and higher-than-allowed acid levels above the specified limits (1.2% for Griseofulvic Acid and 0.18% for an unknown impurity) can compromise the drug's safety profile and effectiveness in treating fungal infections in horses.

What You Should Do

Check your horse's medication for Griseofulvin Powder (microsize) 2.5 g Active Ingredient in 15-gram pre-printed pouches with Product No. 1GRI001.
Verify the lot number and expiration date on the packaging: look specifically for Lot 54340006 with an expiration date of 09/2018.
Identify the product by its National Drug Code (NDC): 61133-5434-1.
Contact your veterinarian or pharmacist for guidance regarding the use of this affected lot.
Return any unused pouches to the place of purchase for a refund and contact Bimeda, Inc. for further instructions.
For additional questions, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002 or via their website.

Your Remedy Options

Full Refund

Veterinary drug 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: Griseofulvin Powder (microsize) For Oral Use In Horses (15 grams)

Model:

1GRI001

NDC: 61133-5434-1

V-0285-2018

Lot Numbers:

54340006 (Exp 09/2018)

Date Ranges: 09/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80929

Status: Resolved

Manufacturer: Bimeda, Inc.

Manufactured In: United States

Units Affected: 10,050 pouches

Distributed To: Colorado, Missouri, Ohio, Idaho, Massachusetts, Kansas, Florida

Agency Last Updated: September 18, 2018

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

What You Should Do

Check your horse's medication for Griseofulvin Powder (microsize) 2.5 g Active Ingredient in 15-gram pre-printed pouches with Product No. 1GRI001.

Verify the lot number and expiration date on the packaging: look specifically for Lot 54340006 with an expiration date of 09/2018.

Identify the product by its National Drug Code (NDC): 61133-5434-1.

Contact your veterinarian or pharmacist for guidance regarding the use of this affected lot.

Return any unused pouches to the place of purchase for a refund and contact Bimeda, Inc. for further instructions.

For additional questions, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002 or via their website.