Drug product
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77
D-0146-2021
Product summary
- Event
- Event 86925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,848 cartons
- Official record key
drug-enforcement:D-0146-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: M900412 December 2020 M904772 February 2021 M915745 October 2021
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications