Reported Jan 26, 2022 · Terminated

Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC…

VistaPharm, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: VistaPharm, Inc. · 7265 Ulmerton Rd · Largo, FL · 33771-4809

Is this the product you have?

    • Clobazam Oral Suspension 2.5 mg/mL
    • 120 mL bottles
    • Rx only
  • Manufactured byVistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Lot codes and dates
    • 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
Amount recalled
18,456 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Stability Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 13, 2024 · Data as of Sep 19, 8:04 PM UTC

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