Recalls / Class II
Class IID-0376-2022
Product
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
- Affected lot / code info
- 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
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 18,456 bottles
- Distribution pattern
- Nationwide within the United States including Puerto Rico
Timeline
- Recall initiated
- 2022-01-07
- FDA classified
- 2022-01-18
- Posted by FDA
- 2022-01-26
- Terminated
- 2024-12-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0376-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.