Drug product
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
D-0376-2022
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 89395
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,456 bottles
- Official record key
drug-enforcement:D-0376-2022
Official wording
Reason: Failed Stability Specifications
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
Distribution pattern: Nationwide within the United States including Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications