Why it was recalled
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Product description
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count 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 # 411987 Exp: 05/2025
Where it was sold
Nationwide in the USA
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-0318-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 1, 2024
- FDA report date
- Feb 14, 2024
- Quantity
- 4260 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NATCO Pharma Limited
Original FDA data
Every field from FDA enforcement report D-0318-2024, exactly as published.
Show all FDA fields
- City
- Rangareddy
- Status
- Terminated
- Country
- India
- Event ID
- 93868
- Address
- Pharma Division, Kothur Village
- Code information
- Lot # 411987 Exp: 05/2025
- Report date
- Feb 14, 2024
- Product type
- Drugs
- Recall number
- D-0318-2024
- Classification
- Class II
- Recalling firm
- NATCO Pharma Limited
- Product quantity
- 4260 bottles
- Termination date
- Feb 6, 2026
- Reason for recall
- CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count 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 USA
- Recall initiation date
- Feb 1, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2024