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
D-0564-2024
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 94681
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 84,710 cartridges
- Official record key
drug-enforcement:D-0564-2024
Official wording
Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Code information: Lot#: HJ3965; Exp 2024/09 Lot#: HJ8546; Exp 2024/10
Distribution pattern: US Nationwide and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility