Why it was recalled
Failed Stability Specifications
Product description
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Lot numbers, UPCs & expiration codes
Lots #: 678900, 682000, 682400, Exp. 5/31/2022; 680600, 680800, 681000 Exp. 5/30/2022; 683200, 685200 Exp. 6/30/2022; 728900, 733100 Exp. Date 12/31/2022; 738600 Exp. 1/31/2023; 740600, 741600 Exp. 2/28/2023; 749800, 750900, 752400 Exp. 3/31/2023; 775700 Exp. 6/30/2023
Where it was sold
Nationwide within the United States including Puerto Rico
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-0376-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 7, 2022
- FDA report date
- Jan 26, 2022
- Quantity
- 18,456 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0376-2022, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89395
- Address
- 7265 Ulmerton Rd
- Code information
- Lots #: 678900, 682000, 682400, Exp. 5/31/2022; 680600, 680800, 681000 Exp. 5/30/2022; 683200, 685200 Exp. 6/30/2022; 728900, 733100 Exp. Date 12/31/2022; 738600 Exp. 1/31/2023; 740600, 741600 Exp. 2/28/2023; 749800, 750900, 752400 Exp. 3/31/2023; 775700 Exp. 6/30/2023
- Postal code
- 33771-4809
- Report date
- Jan 26, 2022
- Product type
- Drugs
- Recall number
- D-0376-2022
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 18,456 bottles
- Termination date
- Dec 13, 2024
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
- Distribution pattern
- Nationwide within the United States including Puerto Rico
- Recall initiation date
- Jan 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 18, 2022