FDA recall D-0064-2023

Product

PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.

Reason for recall

CGMP Deviations: Potential for cross contamination due to product carry over.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-11-10

Report date

2022-11-23

Termination date

2024-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0064-2023