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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Vet
Pets & Animals/Pet Medications

Syndel USA: Tricaine-S (Tricaine Methanesulfonate) Recalled for Failed Purity Testing

Agency Publication Date: February 12, 2020
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Summary

Syndel USA has recalled approximately 102 kilograms of Tricaine-S (tricaine methanesulfonate) after stability testing revealed that the product failed purity standards at the 30-month mark. This recall affects three different sizes of the product: 1-kilogram, 100-gram, and 10-gram containers. Approximately 102 units were distributed to 13 distributors and 28 users across multiple states. If you have any of the affected product from Lot 12351, it may no longer meet the quality specifications required for its intended use as a veterinary anesthetic.

Risk

The product failed its purity assay during long-term stability testing, meaning it may not contain the correct concentration of active ingredients or may contain impurities. This could result in ineffective anesthesia or unpredictable results when used on animals.

What You Should Do

  1. Check your supply of Tricaine-S (tricaine methanesulfonate) for Lot 12351 with an expiration date of July 2020 (7/2020).
  2. If you identify product from the affected lot, stop using it immediately to ensure the safety and effective treatment of animals.
  3. Contact your veterinarian, healthcare provider, or pharmacist for guidance on alternative products or if you have concerns about animals previously treated with this batch.
  4. Return any unused product from Lot 12351 to the place of purchase for a refund and contact Syndel USA at their Ferndale, Washington location for further instructions.
  5. For additional questions or to report issues, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Tricaine-S (tricaine methanesulfonate) 1 Kilogram
Model:
ANADA #200-226
Lot Numbers:
12351 (Exp. Date 7/2020)
Date Ranges: Expiration Date 7/2020
Product: Tricaine-S (tricaine methanesulfonate) 100 grams
Model:
ANADA #200-226
Lot Numbers:
12351 (Exp. Date 7/2020)
Date Ranges: Expiration Date 7/2020
Product: Tricaine-S (tricaine methanesulfonate) 10 grams
Model:
ANADA #200-226
Lot Numbers:
12351 (Exp. Date 7/2020)
Date Ranges: Expiration Date 7/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84847
Status: Resolved
Manufacturer: Syndel USA
Sold By: Distributors; Specialty retailers
Manufactured In: United States
Units Affected: 102.47 kg
Distributed To: Arizona, Arkansas, California, Idaho, Massachusetts, Maine, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Oregon, Pennsylvania, Texas, Washington
Agency Last Updated: February 26, 2020

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