Home / Recalls / Lupin Pharmaceuticals Inc. / D-0974-2017

D-0974-2017 Class III Terminated

Recalled by Lupin Pharmaceuticals Inc. — Baltimore, MD

Recall Details

Product Type
Drugs
Report Date
July 19, 2017
Initiation Date
June 22, 2017
Termination Date
January 17, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12480 bottles

Product Description

Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06

Reason for Recall

Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019

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