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
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.
Lot numbers, UPCs & expiration codes
Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0129-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 10, 2023
- FDA report date
- Dec 6, 2023
- Quantity
- 2502 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0129-2024, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 93431
- Address
- 5187 Camino Ruiz
- Code information
- Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;
- Postal code
- 93012-8601
- Report date
- Dec 6, 2023
- Product type
- Drugs
- Recall number
- D-0129-2024
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 2502 bottles
- Termination date
- Mar 21, 2025
- Reason for recall
- Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 10, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 30, 2023