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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

TEVA Animal Health Inc: Praziquantel Injection Recalled for Appearance and Manufacturing Defects

Agency Publication Date: September 8, 2009
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Summary

TEVA Animal Health Inc. is recalling approximately 5,475 vials of Praziquantel Injection (56.8 mg/ml), a veterinary medication used to treat parasites. The recall was initiated because the product does not meet physical appearance standards and was not manufactured according to required Good Manufacturing Practices (GMP). This recall affects products sold under the brand names VEDCO Cestoved, Butler Praziject, and Phoenix Pharmaceutical Inc. CestaJect. Owners of animals that have received this medication should consult their veterinarian or pharmacist regarding the next steps for their pet's care.

Risk

Failure to follow proper manufacturing standards can compromise the sterility, stability, or potency of the medication, potentially leading to ineffective treatment or adverse reactions in animals.

What You Should Do

  1. Check your veterinary supplies for 10-ml vials of Praziquantel Injection (56.8 mg/ml) under the brand names VEDCO Cestoved, Butler Praziject, or Phoenix Pharmaceutical Inc. CestaJect.
  2. Verify if your product is affected by looking for ANDA number 200-176 on the label and checking if the manufacturer is TEVA Animal Health Inc or IVX Animal Health Inc.
  3. Stop using the affected medication immediately and quarantine any remaining vials to ensure they are not administered to animals.
  4. Contact your veterinarian or pharmacist to discuss alternative treatments and to report the use of any affected product.
  5. Return any unused product to the place of purchase (such as your veterinary clinic or distributor) for a refund and contact TEVA Animal Health Inc. for further instructions.
  6. For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Veterinary drug return and consultation

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

Affected Products

Product: VEDCO Cestoved (Praziquantel Injection, 56.8 mg/ml) 10-ml vials
Model:
ANDA 200-176
Product: Butler Praziject (Praziquantel Injection, 56.8 mg/ml) 10-ml vials
Model:
ANDA 200-176
Product: Phoenix Pharmaceutical Inc. CestaJect (Praziquantel Injection, 56.8 mg/ml) 10-ml vials
Model:
ANDA 200-176

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 52058
Status: Resolved
Manufacturer: TEVA Animal Health Inc
Sold By: Vedco, Inc.; Butler Animal Health Supply; Phoenix Pharmaceutical Inc.; veterinary drug distributors
Manufactured In: United States
Units Affected: 5,475/10-ml. vials
Distributed To: Nationwide

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 ยท Raw API Response