FDA Drug · D-0564-2024

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03

Class II · Ongoing

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Affected lots / codes — check yours against thisLot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10

Recalling firm: Pfizer Inc., New York, NY
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 84,710 cartridges
Distribution: US Nationwide and Puerto Rico.
Recall initiated: May 20, 2024
Classified: June 22, 2024
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0564-2024%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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