Drug recall D-0027-2022

Class II Terminated reported Oct 27, 2021

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

Reason for recall

Out of specification result observed in a dissolution test at the 9-month long term stability time point.

Lots and codes

lot H002205, exp. date 08/2023

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
1,902 bottles
Distribution
Distributed Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
October 8, 2021
Terminated
March 13, 2023

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