Lupin Pharmaceuticals Inc. recalls Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
Recalled July 19, 2017 · FDA recall D-0974-2017 · Lupin Pharmaceuticals
Hazard
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study. · FDA Class III
Units
12480 bottles
Sold at
Nationwide in the USA
Description
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Product
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
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →