D-0027-2022 Class II Terminated
FDA drug recall D-0027-2022 was initiated by Lupin Pharmaceuticals Inc. on October 8, 2021 and is designated Class II. Reason for recall: Out of specification result observed in a dissolution test at the 9-month long term stability time point. The recall status is terminated (terminated March 13, 2023). Affected quantity: 1,902 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 27, 2021
- Initiation Date
- October 8, 2021
- Termination Date
- March 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,902 bottles
Product Description
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
Reason for Recall
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Distribution Pattern
Distributed Nationwide in the USA.
Code Information
lot H002205, exp. date 08/2023