Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR ...
FDA Recall #D-0205-2024 — Class II — December 11, 2023
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
Reason for Recall
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Recalling Firm
Legacy Pharmaceutical Packaging LLC — Earth City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
161,664 bottles
Distribution
CA and AR
Code Information
Lot #: 222033, exp. date 08/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated