Cox Veterinary Laboratory, Inc.: Gastroade Xtra (Omeprazole) Paste Recalled for Lack of FDA Approval

Agency Publication Date: February 14, 2015

Summary

Cox Veterinary Laboratory, Inc. is recalling 10,571 units of Gastroade Xtra (omeprazole) paste. This product is being recalled because it is an unapproved new animal drug, meaning its safety and effectiveness have not been reviewed by the FDA for use in animals. The recall affects 32 ml tubes from batch #005 that were distributed across 17 states.

Risk

Using unapproved animal drugs poses a risk because the products have not undergone FDA scrutiny for safety, quality, or efficacy. This could result in ineffective treatment for animal conditions or exposure to unknown safety risks.

What You Should Do

Check your supply for Gastroade Xtra (Omeprazole) paste in 32 ml tubes with Batch #005 and UPC 091037382986.
Verify if the product was manufactured on 5/29/2014 by checking the packaging details.
Immediately stop using the product on any animals if it matches the recalled batch information.
Contact your veterinarian or healthcare provider to discuss alternative treatments or for guidance regarding any animals that have used this product.
Return any unused portions of the recalled paste to the place of purchase for a refund or contact Cox Veterinary Laboratory, Inc. directly at their Chester, SC location for further instructions.
For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

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

How to: Contact your veterinarian or pharmacist for guidance. Return any unused product to the place of purchase for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Gastroade Xtra (Omeprazole) paste (32 ml)

Model:

V-232-2015

UPC Codes:

091037382986

Lot Numbers:

005

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70358

Status: Resolved

Manufacturer: Cox Veterinary Laboratory, Inc.

Sold By: Cox Veterinary Laboratory, Inc.

Manufactured In: United States

Units Affected: 10,571 units

Distributed To: Arkansas, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia

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 Gastroade Xtra (Omeprazole) paste in 32 ml tubes with Batch #005 and UPC 091037382986.

Verify if the product was manufactured on 5/29/2014 by checking the packaging details.

Immediately stop using the product on any animals if it matches the recalled batch information.

Contact your veterinarian or healthcare provider to discuss alternative treatments or for guidance regarding any animals that have used this product.

Return any unused portions of the recalled paste to the place of purchase for a refund or contact Cox Veterinary Laboratory, Inc. directly at their Chester, SC location for further instructions.

For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

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

How to: Contact your veterinarian or pharmacist for guidance. Return any unused product to the place of purchase for a refund and contact the manufacturer for further instructions.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70358

Status: Resolved

Manufacturer: Cox Veterinary Laboratory, Inc.

Sold By: Cox Veterinary Laboratory, Inc.

Manufactured In: United States

Units Affected: 10,571 units

Distributed To: Arkansas, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia