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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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Medium RiskFDA Vet
Pets & Animals/Pet Medications

KRS Global Biotechnology, Inc: L-Asparaginase Injectable Recalled Due to Lack of Sterility Assurance

Agency Publication Date: October 3, 2019
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Summary

KRS Global Biotechnology, Inc. is recalling 1,141 vials of L-Asparaginase (10,000 International Units per vial), a lyophilized prescription medication for IV, IM, or SC use. This recall was initiated because the product lacks sterility assurance, meaning the vials may contain microorganisms that should not be present in an injectable drug. Consumers who have these vials should not use them and should immediately contact their veterinarian or healthcare provider, as the product is intended for veterinary use.

Risk

A lack of sterility in an injectable medication can lead to serious, potentially life-threatening infections at the site of injection or in the bloodstream. While no specific injuries have been reported, the contamination of a sterile drug product poses a significant health risk to the animals receiving it.

What You Should Do

  1. Check your medical supplies for L-Asparaginase 10,000 International Units/Vial Lyophilized for IV/IM/SC Use labeled as 'Rx Only' from KRS Global Biotechnology.
  2. Verify if your product is affected by checking the lot information; all lots that have not yet reached their expiration date are included in this recall.
  3. Immediately stop using any affected vials and quarantine them to ensure they are not administered.
  4. Contact your veterinarian or healthcare provider to discuss alternative treatments and to report any adverse health effects observed in animals treated with this product.
  5. Return any unused vials to the place of purchase for a refund and contact KRS Global Biotechnology at 791 Park of Commerce Blvd, Boca Raton, FL 33487 for further instructions.
  6. For additional questions or to report issues, contact the FDA Center for Veterinary Medicine at 1-240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Product return for refund and healthcare consultation

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

Affected Products

Product: L-Asparaginase 10,000 International Units/Vial Lyophilized For IV/IM/SC Use (1141 vials)
Model:
V-0048-2020
Lot Numbers:
All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83790
Status: Resolved
Manufacturer: KRS Global Biotechnology, Inc
Manufactured In: United States
Units Affected: 1141 vials
Distributed To: Nationwide
Agency Last Updated: October 15, 2019

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 ยท Raw API Response