Paroxetine Tablet, Film Coated
FDA Recall NDC 60429-737
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Paroxetine (NDC 60429-737). A significant event, classified as Class II, was initiated on Nov 10, 2023 by Golden State Medical Supply, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2023 Class II Recall: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Nov 10, 2023
Dec 06, 2023
5626 bottles
Recall Profile & Regulatory Data
Event ID
93431
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 21, 2025
Product 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.
Batch or Lot Expiration Information
Lot# a) GS036488, GS037091, GS037701, Exp. 08/31/2024; b) GS037090, GS037702, Exp. 08/31/2024; c) GS036677, GS037117, GS037699, Exp. 08/31/2024
Affected Packages Involved in this Recall
60429-734-30Product
60429-734-90Product
60429-734-10Product
60429-735-30Product
60429-735-90Product
60429-735-10Product
60429-736-30Product
60429-736-90Product
60429-736-10Product
60429-737-30Product
60429-737-90Product
60429-737-10Product
November 2023 Class II Recall: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Nov 10, 2023
Dec 06, 2023
2502 bottles
Recall Profile & Regulatory Data
Event ID
93431
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 21, 2025
Product Description
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.
Batch or Lot Expiration Information
Lot# a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024
Affected Packages Involved in this Recall
60429-734-30Product
60429-734-90Product
60429-734-10Product
60429-735-30Product
60429-735-90Product
60429-735-10Product
60429-736-30Product
60429-736-90Product
60429-736-10Product
60429-737-30Product
60429-737-90Product
60429-737-10Product
November 2023 Class II Recall: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Nov 10, 2023
Dec 06, 2023
1941 bottles
Recall Profile & Regulatory Data
Event ID
93431
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 21, 2025
Product Description
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.
Batch or Lot Expiration Information
Lot# a) Lot GS041383, GS042141, Exp. 08/31/2024; b) Lot GS040841, Lot GS041384, Lot GS042039, Exp. 08/31/2024; c) Lot GS040910, Lot GS041621, Lot GS042237, Exp. 08/31/2024
Affected Packages Involved in this Recall
60429-734-30Product
60429-734-90Product
60429-734-10Product
60429-735-30Product
60429-735-90Product
60429-735-10Product
60429-736-30Product
60429-736-90Product
60429-736-10Product
60429-737-30Product
60429-737-90Product
60429-737-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
