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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 Drug
Medications & Supplements/Prescription Drugs

Buprenorphine and Labetalol Hydrochloride Injections Recalled for Sterility

Agency Publication Date: June 22, 2024
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Summary

Pfizer Inc. is recalling 305,110 cartridges of Buprenorphine Hydrochloride Injection (0.3 mg base/mL) and Labetalol Hydrochloride Injection (5 mg/mL) sold under the Hospira label. The recall is due to a potential lack of sterility assurance caused by incomplete crimp seals on the sterile cartridge units. These injectable medications were distributed to hospitals and clinics throughout the United States and Puerto Rico.

Risk

Incomplete crimp seals can compromise the sterility of the injectable medication, potentially leading to systemic infections or other serious health complications for patients receiving the drug. No reports of adverse events or injuries related to this issue have been mentioned in the recall data.

What You Should Do

  1. This recall affects Buprenorphine Hydrochloride Injection (NDC 0409-2012-03) and Labetalol Hydrochloride Injection (NDC 0409-2339-24) in Single-dose Carpuject sterile cartridge units with Luer Locks distributed by Hospira, Inc.
  2. Check your inventory for Buprenorphine lots HJ3965 (Exp 2024/09) and HJ8546 (Exp 2024/10).
  3. Check your inventory for Labetalol lots HJ7566 (Exp 2025/05), HN8747 (Exp 2025/09), and HN8749 (Exp 2025/09).
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Buprenorphine Hydrochloride Injection (0.3 mg base/mL)by Hospira
Variants: 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock
Lot Numbers:
HJ3965 (Exp 2024/09)
HJ8546 (Exp 2024/10)
NDC:
0409-2012-03
Product: Labetalol Hydrochloride Injection, USP (20 mg/4 mL)by Hospira
Variants: 5 mg/mL, 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock
Lot Numbers:
HJ7566 (Exp 2025/05)
HN8747 (Exp 2025/09)
HN8749 (Exp 2025/09)
NDC:
0409-2339-24

Product Images

Buprenorphine Hydrochloride Injection, 1 mL Carpuject Single-dose Cartridge

Buprenorphine Hydrochloride Injection, 1 mL Carpuject Single-dose Cartridge

Labetalol Hydrochloride Injection, 4 mL CarpujectTM Single-dose Cartridge

Labetalol Hydrochloride Injection, 4 mL CarpujectTM Single-dose Cartridge

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94681
Status: Active
Manufacturer: Pfizer Inc.
Sold By: Hospitals; Clinics; Wholesalers
Manufactured In: United States
Units Affected: 2 products (84,710 cartridges; 220,400 cartridges)
Distributed To: Nationwide

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 FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.