Drug product
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77
D-0074-2021
Product summary
- Event
- Event 86663
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,840 units
- Official record key
drug-enforcement:D-0074-2021
Official wording
Reason: Failed Dissolution Specification
Code information: Lot # M005681, EXP 3/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification