Drug product
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
D-0438-2024
Product summary
- Event
- Event 94296
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 bottles
- Official record key
drug-enforcement:D-0438-2024
Official wording
Reason: CGMP Deviations
Code information: Lot#: 411988, Exp date: 05/31/2025
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations