FDAFDA · Food and drugs·Recall number D-0974-2017
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
Published July 19, 2017 · Recall initiated: June 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PAROXETINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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