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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: GentaPoult Veterinary Injection Recalled for Manufacturing Errors

Agency Publication Date: September 8, 2009
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Summary

TEVA Animal Health Inc has recalled approximately 18,135 vials of GentaPoult (gentamicin sulfate) Sterile Injection for veterinary use. The recall was initiated because the quantities of sodium acetate and acetic acid were reversed in the manufacturing records and on the product labels, meaning the product does not meet quality standards. These 100-ml vials were distributed to a single veterinary drug distributor in Georgia for use in day-old chickens and young turkeys.

Risk

The product was not manufactured in accordance with Good Manufacturing Practices (GMP), and the ingredients listed on the label do not match the actual contents. This chemical imbalance could affect the stability or safety of the injection when administered to poultry.

What You Should Do

  1. Identify the affected product by checking the label for 'AmTech Group, Inc. GentaPoult (Gentamicin Sulfate Injection) Sterile Injection Veterinary' in 100-ml vials.
  2. Check the manufacturer name on the label; affected products list 'Manufactured by IVX Animal Health, Inc., St. Joseph, MO' and are associated with ANDA 200-147.
  3. Immediately stop using any vials from this batch and sequester them to prevent further administration to livestock.
  4. Contact your veterinarian, healthcare provider, or pharmacist for guidance regarding the use of this medication and to report any adverse effects in treated animals.
  5. Return any unused vials to the veterinary distributor or place of purchase for a refund.
  6. Contact TEVA Animal Health Inc at their Saint Joseph, Missouri facility for specific instructions on returning the product and receiving credit.
  7. For additional questions, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Veterinary drug refund and guidance

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

Affected Products

Product: AmTech Group, Inc. GentaPoult (Gentamicin Sulfate Injection) Sterile Injection Veterinary (100-ml vial)
Model:
ANDA 200-147
V-271-2009

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 52095
Status: Resolved
Manufacturer: TEVA Animal Health Inc
Sold By: veterinary drug distributor
Manufactured In: United States
Units Affected: 18,135/100-ml. vials
Distributed To: Georgia

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