FDA Drug Class III — Least Serious

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

Hazard

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

Products

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.) 4
Brand
Lupin Pharmaceuticals Inc.
UPC
Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019

Units Affected

12480 bottles