FDA-Drug2024-01-03Class II

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

Legacy Pharmaceutical Packaging LLC
Hazard

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

Sold states
CA and AR
Affected count
161,664 bottles
Manufactured in
13333 Lakefront Dr, Earth City, MO, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0205-2024

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