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PAROXETINE HYDROCHLORIDE ANHYDROUS Recall D-0130-2024

Description: PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

PAROXETINE HYDROCHLORIDE ANHYDROUS Recall D-0130-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0130-2024
Event ID93431
BrandPAROXETINE
Generic NamePAROXETINE HYDROCHLORIDE
ManufacturerPAROXETINE HYDROCHLORIDE
Active SubstancePAROXETINE HYDROCHLORIDE ANHYDROUS
Drug RouteORAL
DistributionNationwide in the USA
Quantity5626 bottles
Recall ReasonFailed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Drug ClassificationClass II
Drug Code Info20231206
Product NDC60429-734 60429-735 60429-736
Recall Initiation Date20231110
Report Date20231206
Classification Date20231130
Address5187 Camino Ruiz
Camarillo, CA 93012-8601
United States
Recalling FirmGolden State Medical Supply Inc.
Initial Notification Letter
Unique Ingredient Identifier3I3T11UD2S
Drug Application NumberANDA075356
Structured Product Labeling (SPL ID)091f4195-a70a-ae35-e063-6294a90a3e89
Structured Product Labeling (SPL Set ID)e63fe922-b35a-406c-8737-f3f5e6d5a30d
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