Drug product
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
D-0565-2024
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 94681
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 220,400 cartridges
- Official record key
drug-enforcement:D-0565-2024
Official wording
Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Code information: Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
Distribution pattern: US Nationwide and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility