Recall: D-0565-2024

Class II - Potentially Harmful

Class IIClassification

2024-05-20Initiated

OngoingStatus

Pfizer Inc.Firm

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

Reason

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Distribution

US Nationwide and Puerto Rico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.