FDA recall D-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

Reason for recall

Failed Stability Specifications

Distribution

Nationwide within the United States including Puerto Rico

Key facts

Status

Terminated

Initiation date

2022-01-07

Report date

2022-01-26

Termination date

2024-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0376-2022