Recalls / Class II
Class IID-0128-2024
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.
- Brand name
- Paroxetine
- Generic name
- Paroxetine Hydrochloride
- Active ingredient
- Paroxetine Hydrochloride Anhydrous
- Route
- Oral
- NDCs
- 60429-734, 60429-735, 60429-736, 60429-737
- FDA application
- ANDA075356
- Affected lot / code info
- 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;
Why it was recalled
Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Quantity
- 1941 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-10
- FDA classified
- 2023-11-30
- Posted by FDA
- 2023-12-06
- Terminated
- 2025-03-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0128-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.