Drug product
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
D-0027-2022
Product summary
- Event
- Event 88838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,902 bottles
- Official record key
drug-enforcement:D-0027-2022
Official wording
Reason: Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Code information: lot H002205, exp. date 08/2023
Distribution pattern: Distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of specification