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Class II: temporary or reversible health riskTerminated

Bionpharma Clobazam Oral Suspension Recall

Clobazam Oral Suspension, 2

Bionpharma Inc. · Princeton, NJ

Risk level
Class II
Reported by FDA
Jul 31, 2019
Recall ID
D-1519-2019
Check your lot numberHow we source this data

Summary

Bionpharma recalled Clobazam Oral Suspension starting Jul 16, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1519-2019 on Jul 31, 2019. Reason: Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. Status: Terminated.

Why it was recalled

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

Product description

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 numbers, UPCs & expiration codes

Lot #: 18246, Exp 09/2020

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1519-2019
Classification
Class II
Status
Terminated
Recall initiated
Jul 16, 2019
FDA report date
Jul 31, 2019
Quantity
3,020 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Bionpharma Inc.

Original FDA data

Every field from FDA enforcement report D-1519-2019, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
83356
Address
600 Alexander Rd Ste 2-4b
Code information
Lot #: 18246, Exp 09/2020
Postal code
08540-6013
Report date
Jul 31, 2019
Product type
Drugs
Recall number
D-1519-2019
Classification
Class II
Recalling firm
Bionpharma Inc.
Product quantity
3,020 bottles
Termination date
Mar 5, 2020
Reason for recall
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
Nationwide in the USA
Recall initiation date
Jul 16, 2019
Initial firm notification
Letter
Center classification date
Jul 25, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1519-2019, published Jul 31, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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