Why it was recalled
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Product description
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
Lot numbers, UPCs & expiration codes
Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021
Where it was sold
Distributed 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-0112-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 17, 2020
- FDA report date
- Dec 9, 2020
- Quantity
- 11,922 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0112-2021, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 86786
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: GS026353, GS027150, GS027653, GS028044, Exp. Date: 02/2021
- Postal code
- 93012-8601
- Report date
- Dec 9, 2020
- Product type
- Drugs
- Recall number
- D-0112-2021
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 11,922 bottles
- Termination date
- Jul 22, 2022
- Reason for recall
- FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 30, 2020