Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 666
Summary
The FDA issued a Class II for Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: V by VistaPharm, Inc.. Reason: Failed Stability Specifications.
Details
Source
Drug Recall
External ID
D-0376-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
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/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
Quantity Affected: 18,456 bottles
Reason for Recall
Failed Stability Specifications
Distribution
Nationwide within the United States including Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-07
Company
Largo, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
VistaPharm, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VistaPharm, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VistaPharm, Inc. have FDA actions?
VistaPharm, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0376-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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