Pfizer Inc. recalls Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Lu
Recalled July 3, 2024 · FDA recall D-0565-2024 · Pfizer
Hazard
Lack of Assurance of Sterility-The potential for incomplete crimp seals. · FDA Class II
Units
220,400 cartridges
Sold at
US Nationwide and Puerto Rico.
Description
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
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
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →