← FDA ENFORCEMENT
D-0205-2024Class II

Legacy Pharmaceutical Packaging LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Legacy Pharmaceutical Packaging LLC
Product type
Drug
Status
Ongoing
Report date
2024-01-03
Distribution
CA and AR
Firm state
MO
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

Data: U.S. FDA. 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. Open the enforcement explorer →