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FDARecalled Dec 6, 2023 · #D-0128-2024

PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc.,...

Hazard

Class II — temporary health risk

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Description

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine Classification: Class II Distribution: Nationwide in the USA

Product details

Product
PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Type
Drugs
Manufacturer
Golden State Medical Supply Inc.
Model numbers
GS041383, GS040841, GS041384, GS042039, GS040910, GS041621, GS042237
UPCs