FDA recall D-0027-2022

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.

Distribution

Distributed Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2021-10-08

Report date

2021-10-27

Termination date

2023-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0027-2022