PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90... — FDA record D-0130-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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.
Reason
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
Recalling firm
Golden State Medical Supply Inc.
Quantity
5626 bottles
Agency-reported status
Terminated
Source record identifier
D-0130-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot # a) GS036488, GS037091, GS037701, Exp. 08/31/2024; b) GS037090, GS037702, Exp. 08/31/2024; c) GS036677, GS037117, GS037699, Exp. 08/31/2024

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Dec 6, 2023
Recall initiation date
Nov 10, 2023
Center classification date
Nov 30, 2023
Termination date
Mar 21, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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