Intervet Inc.: Regu-Mate (altrenogest) Oral Solution Recalled Due to Leaking Bottles

Agency Publication Date: July 20, 2004

Summary

Intervet Inc. has recalled approximately 8,037 bottles of Regu-Mate (altrenogest) Oral Progestin 0.22% Solution because the one-liter bottles may leak. This veterinary medication is used for horses and was shipped in cases containing six bottles each. The recall affects bottles with NDC number 057926*101 and NADA number 131-310. Owners should contact their veterinarian or pharmacist immediately regarding any unused product.

Risk

Leaking bottles can lead to unintended skin exposure to the progestin solution for handlers or animal owners. Altrenogest is a hormone that can be absorbed through the skin and may cause reproductive or health complications in humans if not handled according to safety directions.

What You Should Do

Check your supply for one-liter bottles of Regu-Mate (altrenogest) Oral Progestin 0.22% Solution with NDC number 057926*101 and NADA number 131-310.
Inspect the bottles carefully for any signs of liquid leakage or residue around the cap and seal area.
If you identify a leaking bottle or have unused product from the affected batch, contact your veterinarian or pharmacist for guidance on how to handle the product.
Return any unused or leaking product to the place of purchase (veterinary supply company or distributor) for a refund and contact Intervet Inc. for further instructions.
Contact the FDA Center for Veterinary Medicine for additional questions at 240-402-7002.

Your Remedy Options

Full Refund

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: Regu-Mate (altrenogest) Oral Progestin 0.22% Solution (1,000 ml)

Model:

NDC 057926*101

NADA 131-310

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 28449

Status: Resolved

Manufacturer: Intervet Inc.

Sold By: veterinary supply companies; distributors

Manufactured In: United States

Units Affected: 8037 bottles

Distributed To: Nationwide

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 supply for one-liter bottles of Regu-Mate (altrenogest) Oral Progestin 0.22% Solution with NDC number 057926*101 and NADA number 131-310.

Inspect the bottles carefully for any signs of liquid leakage or residue around the cap and seal area.

If you identify a leaking bottle or have unused product from the affected batch, contact your veterinarian or pharmacist for guidance on how to handle the product.

Return any unused or leaking product to the place of purchase (veterinary supply company or distributor) for a refund and contact Intervet Inc. for further instructions.

Contact the FDA Center for Veterinary Medicine for additional questions at 240-402-7002.