Why it was recalled
CGMP Deviations
Product description
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Lot numbers, UPCs & expiration codes
Lot#: 411988, Exp date: 05/31/2025
Where it was sold
Nationwide in the US
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-0438-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 27, 2024
- FDA report date
- Apr 17, 2024
- Quantity
- 30 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NATCO Pharma Limited
Original FDA data
Every field from FDA enforcement report D-0438-2024, exactly as published.
Show all FDA fields
- City
- Rangareddy
- Status
- Terminated
- Country
- India
- Event ID
- 94296
- Address
- Pharma Division, Kothur Village
- Code information
- Lot#: 411988, Exp date: 05/31/2025
- Report date
- Apr 17, 2024
- Product type
- Drugs
- Recall number
- D-0438-2024
- Classification
- Class II
- Recalling firm
- NATCO Pharma Limited
- Product quantity
- 30 bottles
- Termination date
- Feb 6, 2026
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Mar 27, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 5, 2024