FDAFDA · Food and drugs·Recall number D-0129-2024
PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Published December 6, 2023 · Recall initiated: November 10, 2023
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 Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PAROXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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