Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- VistaPharm, Inc.
- Reason for Recall:
- Failed Stability Specifications
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0376-2022
Related Recalls
Failed Excipient Specifications: high content of ethylene glycol (EG)
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.