RecallDepth
Class II Terminated

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.

Company
Golden State Medical Supply Inc.
Recall Initiated
November 10, 2023
Posted
December 6, 2023
Recall Number
D-0129-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
2502 bottles
Firm Location
Camarillo, CA, United States

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

Nationwide in the USA

Lot / Code Info

Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;

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