Sertraline Tablets recalled over manufacturing violations

Recall date

December 11, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Legacy Pharmaceutical Packaging LLC recalls Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured fo…

Recall number

D-0205-2024

FDA classification

Class II

Brand / firm

Legacy Pharmaceutical Packaging LLC

Sold / distributed

CA and AR

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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