D-0027-2022 Class II Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

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