Drug product
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
D-0318-2024
Product summary
- Event
- Event 93868
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4260 bottles
- Official record key
drug-enforcement:D-0318-2024
Official wording
Reason: 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.
Code information: Lot # 411987 Exp: 05/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations