← FDA ENFORCEMENT
D-0564-2024Class II

Pfizer Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Pfizer Inc.
Product type
Drug
Status
Ongoing
Report date
2024-07-03
Distribution
US Nationwide and Puerto Rico.
Firm state
NY
Product quantity
84,710 cartridges
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →