FDA-Drug2021-10-27Class II

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

Lupin Pharmaceuticals Inc.
Hazard

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

Sold states
Distributed Nationwide in the USA.
Affected count
1,902 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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

Official notice

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

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