Bionpharma Inc. Announces a Voluntary Nationwide Recall of Atovaquone Oral Suspension Because of Bacterial Contamination Issues
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Product found to be contaminated with Cohnella bacteria
- Company Name:
- Bionpharma Inc.
- Brand Name:
-
Brand Name(s)
BionPharma
- Product Description:
-
Product Description
Atovaquone Oral Suspension, 750 mg/mL
Company Announcement
FOR IMMEDIATE RELEASE – September 17, 2024 – Bionpharma Inc. is recalling (1) single Batch (2310083) of its Atovaquone Oral Suspension, 750 mg/mL to the consumer level. This product, produced by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc., has been found to be contaminated with Cohnella bacteria.
Risk Statement: For individuals who are immunocompromised, there is a significant chance that the microbial contamination in Atovaquone Oral Suspension could lead to severe, life-threatening infections such as myocarditis and irreversible soft tissue damage. Currently, Bionpharma has not documented any adverse events linked to this recall.
Bionpharma takes these findings seriously and has initiated an immediate recall for the affected batch, alongside enhanced quality control protocols with CoreRx, Inc. We prioritize consumer safety and are dedicated to maintaining transparency in addressing this issue.
This formulation is a quinone antimicrobial designed for the prevention of pneumocystis jirovecii pneumonia (previously referred to as PCP). The compromised batch was manufactured at CoreRx, Inc. and distributed nationwide between December 21, 2023, and June 20, 2024. The recall encompasses the following product and batch number:
|
Production Date |
Release Date |
Product Name |
NDC |
Lot No. |
Expiration Date |
|---|---|---|---|---|---|
| October 26, 2023 | December 05, 2023 | Atovaquone Oral Suspension | 69452-252-87 | 2310083 | September 2025 |
The product can be recognized by the HDPE white bottle shown below.
To locate the lot number, check the side panel of the bottle or the bottom flap of the packaging.
The company is reaching out to its distributors and customers via email to facilitate returns or replacements for the affected batch. Distributors and retailers with this lot number should immediately halt distribution and withdraw it from their inventory. Consumers in possession of the affected lot should discontinue use and return the product to the place of purchase.
For inquiries regarding this recall, consumers can contact Bionpharma at (888) 235-2466 (Monday to Friday, 9 AM to 5 PM EST) or email drugsafety@bionpharma.com. Those who have experienced issues related to the affected batch should consult their physician or healthcare provider.
Any adverse reactions or quality issues associated with this product can be reported to the FDA’s MedWatch Adverse Event Reporting program through various avenues such as online, mail, or fax.
- To submit a report Online
- By Mail or Fax: Download the form or call 1-800-332-1088 to request a form, complete it, and send it to the provided address, or submit by fax to 1-800-FDA-0178
This recall is being carried out with the oversight of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- Drug Safety Department, Bionpharma Inc.
- 1-888-235-2466