Drug product
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.
D-0738-2022
Product summary
- Event
- Event 89871
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,703 bottles
- Official record key
drug-enforcement:D-0738-2022
Official wording
Reason: Failed Dissolution Specifications; during long term stability testing.
Code information: Lot# C2102911, Exp. 12/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications