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Low RiskFDA Vet
Medications & Supplements/Veterinary Medicines

Boehringer Ingelheim Vetmedica Inc: Sulmet Drinking Water Solution Recalled for Foreign Particulate Matter

Agency Publication Date: October 15, 2015
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Summary

Boehringer Ingelheim Vetmedica Inc has recalled 43,716 16-ounce containers and 5,448 gallon containers of Sulmet (sulfamethazine sodium) Drinking Water Solution, 12.5%. This veterinary antibacterial medication was found to contain particulate matter that is not part of the normal manufacturing process. This contamination could potentially cause physical irritation or reduce the effectiveness of the treatment for the animals. These products were sold through distributors and retailers across 29 states and Puerto Rico between approximately 2012 and 2015.

Risk

The presence of foreign particulate matter in the medication can interfere with the physical properties of the solution, potentially leading to incorrect dosing or unintended physical side effects in livestock. Although the risk level is classified as low, foreign objects in pharmaceutical products pose a quality and safety hazard to treated animals.

What You Should Do

  1. Check your supply for Sulmet (sulfamethazine sodium) Drinking Water Solution, 12.5%, packaged in 16 fl oz (473 ml) or 1-gallon plastic containers.
  2. Locate the lot number and expiration date on the product label. Affected lots include: 120582 (Exp 31 May 15), 120566 (Exp 31 May 15), 120784 (Exp 31 Jul 15), 120922 (Exp 31 Aug 15), 121048 (Exp 30 Sep 15), and 121028 (Exp 30 Sep 15).
  3. Immediately stop using any product identified as part of the affected lots for animal treatment.
  4. Contact your veterinarian or healthcare provider for guidance regarding animals that have received treatment from these specific batches.
  5. Return any unused containers to the place of purchase for a full refund or contact Boehringer Ingelheim Vetmedica Inc at their Saint Joseph, MO headquarters for further instructions.
  6. For additional questions, you may contact the FDA's Center for Veterinary Medicine at 1-888-463-6332.

Your Remedy Options

💰Full Refund

Refund for returned product.

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

Affected Products

Product: Sulmet (sulfamethazine sodium) Drinking Water Solution, 12.5% (16 fl oz)
Model:
NADA 006-084
NDC 0010-4708-01
Lot Numbers:
120582 (Exp 31 May 15)
120566 (Exp 31 May 15)
120784 (Exp 31 Jul 15)
120922 (Exp 31 Aug 15)
121048 (Exp 30 Sep 15)
121028 (Exp 30 Sep 15)
Date Ranges: Expiration 31 May 2015, Expiration 31 Jul 2015, Expiration 31 Aug 2015, Expiration 30 Sep 2015
Product: Sulmet (sulfamethazine sodium) Drinking Water Solution, 12.5% (1 gallon)
Model:
NADA 006-084
NDC 0010-4708-01
Lot Numbers:
120582 (Exp 31 May 15)
120566 (Exp 31 May 15)
120784 (Exp 31 Jul 15)
120922 (Exp 31 Aug 15)
121048 (Exp 30 Sep 15)
121028 (Exp 30 Sep 15)
Date Ranges: Expiration 31 May 2015, Expiration 31 Jul 2015, Expiration 31 Aug 2015, Expiration 30 Sep 2015

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71290
Status: Resolved
Manufacturer: Boehringer Ingelheim Vetmedica Inc
Sold By: distributors; retailers
Manufactured In: United States
Units Affected: 43,716 16-oz containers, 5,448 gallon containers
Distributed To: Alabama, Arkansas, California, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin

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