FDA-Drug2024-07-03Class II

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

Pfizer Inc.
Hazard

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

Sold states
US Nationwide and Puerto Rico.
Affected count
84,710 cartridges
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0564-2024

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