Drug product
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
D-0737-2022
Product summary
- Event
- Event 89871
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,352 bottles (30-count), 1,368 bottles (90-count)
- Official record key
drug-enforcement:D-0737-2022
Official wording
Reason: Failed Dissolution Specifications; during long term stability testing.
Code information: Lot # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications