Legacy Pharmaceutical Packaging LLC: Drug Recall

Recall #D-0205-2024 · 12/11/2023

Class II: Risk

Recall Details

Recall Number
D-0205-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Legacy Pharmaceutical Packaging LLC
Status
Ongoing
Date Initiated
12/11/2023
Location
Earth City, MO, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
161,664 bottles

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

Distribution Pattern

CA and AR

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.