FDA-Drug2017-07-19Class III
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
Lupin Pharmaceuticals Inc.
Hazard
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Sold states
Nationwide in the USA
Affected count
12480 bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
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.) 454 775, India, NDC: 68180-647-06
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0974-2017Don't want to check this manually?
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