Reported Jul 31, 2019 · Terminated

Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road,…

Bionpharma 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: Bionpharma Inc. · 600 Alexander Rd Ste 2-4b · Princeton, NJ · 08540-6013

Is this the product you have?

  • Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only
  • Distributed by
    • Bionpharma Inc
    • 600 Alexander Road
    • Princeton
    • NJ 08540
    • NDC 69452-116-45
Lot codes and dates
    • Lot #: 18246
    • Exp 09/2020
Amount recalled
3,020 bottles

Where it was sold

  • Nationwide

Why it was recalled

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

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 Mar 5, 2020 · Data as of Sep 19, 3:29 PM UTC

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