Drug product
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
D-0853-2022
Product summary
- Event
- Event 90021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 252 Blister Packs
- Official record key
drug-enforcement:D-0853-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: T2000645, Exp 07/2022
Distribution pattern: OH
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications