D-0564-2024 Class II Ongoing

Recalled by Pfizer Inc. — New York, NY

Recall Details

Product Type
Drugs
Report Date
July 3, 2024
Initiation Date
May 20, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
84,710 cartridges

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.

Distribution Pattern

US Nationwide and Puerto Rico.

Code Information

Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10