FDA recall D-0564-2024

Pfizer Inc. · Class II · drug

Product

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

US Nationwide and Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2024-05-20
Report date
2024-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

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