Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartri...
FDA Recall #D-0564-2024 — Class II — May 20, 2024
Product Description
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
Reason for Recall
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
84,710 cartridges
Distribution
US Nationwide and Puerto Rico.
Code Information
Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated