Drug product
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78
D-1288-2022
Product summary
- Event
- Event 90601
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,639 cartons
- Official record key
drug-enforcement:D-1288-2022
Official wording
Reason: FAILED DISSOLUTION SPECIFICATIONS
Code information: Lot T2100515, Exp 01/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
FAILED DISSOLUTION SPECIFICATIONS