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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

Premier Pharmacy Labs Inc: Buprenorphine Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: September 16, 2019
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Summary

Premier Pharmacy Labs Inc is recalling 39 vials of Buprenorphine HCL Injection Preserved, a prescription medication used in veterinary medicine. An FDA inspection revealed that the manufacturing facility had insufficient environmental controls, potential cross-contamination issues, and lacked specific process validations needed to guarantee the product is sterile. Because these vials are intended for injection, any lack of sterility can lead to serious or life-threatening infections in animals. This recall affects all lots that are currently within their expiration dates.

Risk

Injecting a product that is not sterile can introduce bacteria or other contaminants directly into an animal's bloodstream or tissue, potentially causing severe systemic infections or localized abscesses. While no specific injuries have been reported, the manufacturing defects found by the FDA mean the safety of these injections cannot be guaranteed.

What You Should Do

  1. Check your supply for Buprenorphine HCL INJ Preserved, 12mg/20mL (0.6mg/mL) in 20mL multi-dose vials (MDV) with NDC: 69623-703-37 and barcode 6 69623 70337 0.
  2. Verify the lot information; this recall affects all lots of the product that are currently within their expiration dates.
  3. Stop using the affected medication immediately and quarantine any remaining vials to ensure they are not administered to animals.
  4. Contact your veterinarian, healthcare provider, or pharmacist to discuss alternative treatment options and to report any adverse health events.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Premier Pharmacy Labs Inc for further instructions regarding disposal or return.
  6. For additional questions or to report problems, contact the FDA's Center for Veterinary Medicine at 1-888-463-6332.

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: Buprenorphine HCL INJ Preserved, 12mg/20mL (0.6mg/mL), 20mL MDV
Model:
NDC: 69623-703-37
V-0227-2019
UPC Codes:
669623703370
Lot Numbers:
All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83172
Status: Resolved
Manufacturer: Premier Pharmacy Labs Inc
Sold By: Premier Pharmacy Labs Inc
Manufactured In: United States
Units Affected: 39 vials
Distributed To: Nationwide
Agency Last Updated: September 25, 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 · Raw API Response