D-0205-2024Class II

Legacy Pharmaceutical Packaging LLC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-01-03

Distribution

CA and AR

Firm state

Product quantity

161,664 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

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

Product description

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

Code / lot info

Lot #: 222033, exp. date 08/31/2024

Other recalls SPEQ maps to Risk Management & CAPA

2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.

See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.