Medications & Supplements/Prescription Drugs

Atovaquone Oral Suspension Recalled for Microbial Contamination

Agency Publication Date: October 15, 2024

Summary

Bionpharma Inc. is recalling 1,980 bottles of Atovaquone Oral Suspension, USP 750 mg/5 mL (210 mL size), a prescription medication used to treat or prevent certain lung infections. The recall was issued because the product was found to be contaminated with Cohnella bacteria. Consumers should check their medication for Lot # 2310083 with an expiration date of 09/30/2025.

Risk

The presence of Cohnella bacteria in this non-sterile medication poses a risk of infection, which can be particularly dangerous for patients with weakened immune systems who are frequently prescribed this drug. No adverse events or injuries have been reported to date.

What You Should Do

This recall affects Atovaquone Oral Suspension, USP 750 mg/5 mL, sold in 210 mL bottles (NDC 69452-252-87) with Lot # 2310083 and an expiration date of 09/30/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Bionpharma Inc. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atovaquone Oral Suspension, USP 750 mg/5 mL (210 mL bottle)

Variants: 750 mg/5 mL, Oral Suspension, 210 mL

Lot Numbers:

2310083 (Exp. 09/30/2025)

NDC:

69452-252-87

GTIN:

00369452252871

Distributed by Bionpharma Inc.

Product Images

Front of bottle, BionPharma Atovaquone Oral Suspension

Back of bottle, BionPharma Atovaquone Oral Suspension

Front of package, BionPharma Atovaquone Oral Suspension

Back of package, BionPharma Atovaquone Oral Suspension

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95345

Status: Resolved

Manufacturer: Bionpharma Inc.

Manufactured In: United States

Units Affected: 1,980 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 · FDA Press Release · 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.