Class II
Drug Recall: 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.,
Pfizer Inc. · May 20, 2024
Reason for Recall
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
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
Distribution
US Nationwide and Puerto Rico.
States Affected
NATIONWIDE
Quantity Affected
220,400 cartridges
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0565-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.