D-0129-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 6, 2023
- Initiation Date
- November 10, 2023
- Termination Date
- March 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2502 bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Distribution Pattern
Nationwide in the USA
Code Information
Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;