Recalls / Class II
Class IID-0205-2024
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
- Brand name
- Sertraline Hydrochloride
- Generic name
- Sertraline Hydrochloride
- Active ingredient
- Sertraline Hydrochloride
- Route
- Oral
- NDCs
- 68645-521, 68645-522, 68645-523
- FDA application
- ANDA077397
- Affected lot / code info
- Lot #: 222033, exp. date 08/31/2024
Why it was recalled
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Recalling firm
- Firm
- Legacy Pharmaceutical Packaging LLC
- Manufacturer
- Legacy Pharmaceutical Packaging, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 13333 Lakefront Dr, Earth City, Missouri 63045-1514
Distribution
- Quantity
- 161,664 bottles
- Distribution pattern
- CA and AR
Timeline
- Recall initiated
- 2023-12-11
- FDA classified
- 2023-12-26
- Posted by FDA
- 2024-01-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0205-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.