Medications & Supplements/Prescription Drugs

Bionpharma Inc.: Clobazam Oral Suspension Recalled for Microbial Contamination

Agency Publication Date: July 25, 2019

Summary

Bionpharma Inc. is recalling 3,020 bottles of Clobazam Oral Suspension (2.5 mg/mL), a prescription medication used to treat seizures, because the product failed microbial testing. Testing revealed that the non-sterile medication contained higher levels of bacteria or mold than allowed by safety standards. Consumers should contact their healthcare provider or pharmacist immediately for guidance on using this medication and to obtain a replacement.

Risk

The presence of microbial contamination in an oral medication poses a risk of infection or other adverse health reactions. This risk is particularly high for patients with weakened immune systems or other underlying health conditions who may be more susceptible to illness from contaminated products.

What You Should Do

Identify the affected product by checking the label for Clobazam Oral Suspension, 2.5 mg/mL, in a 120 mL bottle.
Check the bottle and packaging for NDC number 69452-116-45 and Lot number 18246 with an expiration date of 09/2020.
Contact your healthcare provider or pharmacist immediately to discuss whether you should continue or stop taking the medication and how to obtain a safe alternative.
Return any unused portions of the affected medication to the pharmacy where you purchased it for a full refund.
For further instructions regarding this recall, contact the manufacturer, Bionpharma Inc., located at 600 Alexander Rd, Princeton, NJ 08540.
For additional questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Full refund and replacement guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Clobazam Oral Suspension, 2.5 mg/mL (120 mL bottle)

Model:

69452-116-45

Lot Numbers:

18246 (Exp 09/2020)

Date Ranges: 09/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83356

Status: Resolved

Manufacturer: Bionpharma Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 3,020 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify the affected product by checking the label for Clobazam Oral Suspension, 2.5 mg/mL, in a 120 mL bottle.

Check the bottle and packaging for NDC number 69452-116-45 and Lot number 18246 with an expiration date of 09/2020.

Contact your healthcare provider or pharmacist immediately to discuss whether you should continue or stop taking the medication and how to obtain a safe alternative.

Return any unused portions of the affected medication to the pharmacy where you purchased it for a full refund.

For further instructions regarding this recall, contact the manufacturer, Bionpharma Inc., located at 600 Alexander Rd, Princeton, NJ 08540.

For additional questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.