Recalling firm
Pfizer Inc.
Product type
Drug
Status
Ongoing
Report date
2024-07-03
Distribution
US Nationwide and Puerto Rico.
Firm state
NY
Product quantity
220,400 cartridges
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason 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
Code / lot info
Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.