FDA recall D-0205-2024

Product

Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54

Reason for recall

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Distribution

CA and AR

Key facts

Status

Ongoing

Initiation date

2023-12-11

Report date

2024-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Earth City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0205-2024