Drug product
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.
D-0129-2024
Product summary
- Event
- Event 93431
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2502 bottles
- Official record key
drug-enforcement:D-0129-2024
Official wording
Reason: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Code information: Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification