Why it was recalled
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
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
Lot numbers, UPCs & expiration codes
Lot #: 222033, exp. date 08/31/2024
Where it was sold
CA and AR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0205-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 11, 2023
- FDA report date
- Jan 3, 2024
- Quantity
- 161,664 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
Original FDA data
Every field from FDA enforcement report D-0205-2024, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 93605
- Address
- 13333 Lakefront Dr
- Code information
- Lot #: 222033, exp. date 08/31/2024
- Postal code
- 63045-1514
- Report date
- Jan 3, 2024
- Product type
- Drugs
- Recall number
- D-0205-2024
- Classification
- Class II
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- Product quantity
- 161,664 bottles
- Reason for recall
- CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- CA and AR
- Recall initiation date
- Dec 11, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 26, 2023