FDA recall D-0961-2022

Nephron Sterile Compounding Center LLC · Class II · drug

Product

Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-05-18
Report date: 2022-06-08
Termination date: 2024-08-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0961-2022