D-0565-2024 Class II Ongoing
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
- 220,400 cartridges
Product Description
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
Reason for Recall
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Distribution Pattern
US Nationwide and Puerto Rico.
Code Information
Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09