Drug product
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
D-0205-2024
Product summary
- Event
- Event 93605
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 161,664 bottles
- Official record key
drug-enforcement:D-0205-2024
Official wording
Reason: CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Code information: Lot #: 222033, exp. date 08/31/2024
Distribution pattern: CA and AR
Derived failure modes
-
Manufacturing or process control
CGMP Deviations