D-0205-2024 Class II Ongoing
FDA drug recall D-0205-2024 was initiated by Legacy Pharmaceutical Packaging LLC on Dec 11, 2023 and is designated Class II. Reason for recall: CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. The recall status is ongoing. Affected quantity: 161,664 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 3, 2024
- Initiation Date
- Dec 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 161,664 bottles
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.
Distribution Pattern
CA and AR
Code Information
Lot #: 222033, exp. date 08/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0205-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026