FDA recall D-0565-2024

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 for recall

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

Distribution

US Nationwide and Puerto Rico.

Key facts

Status

Ongoing

Initiation date

2024-05-20

Report date

2024-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0565-2024