This week, the FDA announced an urgent recall of Atovaquone Oral Suspension. The drug, used to treat fungal infections of the lungs, may contain bacteria that could infect already ill patients. Currently, the recall pertains to a single lot of the medication. However, the seriousness of the potential outcomes associated with the tainted drug is dire. All medical professionals and patients who possess the medication must confirm if their product is included in the recall.
As of the writing of this notice, Bionpharma, Inc. has not received any reports of adverse events related to this recall.
SUMMARY
Date of Recall:
Announced: September 17, 2024
Public Notification: September 18, 2024
Name(s) of Drug:
Atovaquone Oral Suspension, 750 mg/mL
Company Name:
Bionpharma, Inc.
Drug Indication:
Fungal Infection
Product Description
Atovaquone is the generic name for the drug called Mepron. It is available by prescription only and is distributed nationwide by licensed pharmacies and medical facilities. The drug is a liquid contained in white HDPE bottles, each bearing a white label with the drug name in black lettering. The label also contains a yellow band containing the dosage information.
Reason for Recall
Testing revealed that the batch in question contains Cohnella bacteria. In immunocompromised patients who ingest Atovaquone, exposure to the bacteria may be deadly.
Impacts
Atovaquone is an antifungal drug typically prescribed to immunocompromised patients who are at higher risk of infection and whose bodies will struggle to recover. Exposure to the Cohnella bacteria can quickly lead to dangerous and even life-threatening symptoms, particularly in patients who are already ill with a fungal lung infection.
Recall Product Information
All healthcare professionals and consumers who distribute or utilize this medication must carefully examine their stock to ensure they do not administer or consume the recalled drug. You can locate the lot information on the side of the bottle or the back of the box.
If you find that your stock or medication lot is listed below, read further for instructions on taking part in the recall and disposing of the tainted medications.
| Production Date | Release Date | Product Name | NDC | Lot Number | Expiration Date |
| October 26, 2023 | December 5, 2023 | Atovaquone Oral Suspension | 69452-252-87 | 2310083 | September 2025 |
www.fda.gov
Have you found that you are in possession of drugs included in the recall? Here’s what you should do:
Consumers
- Notify your physician if you are in possession of the recalled information.
- Seek immediate medical attention if you have ingested the recalled medication.
- Monitor your health for any adverse symptoms and seek medical attention if you have concerns.
- If you are experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- If you have questions, contact Bionpharma at (888) 235-2466. They are available from 9:00 a.m. to 5:00 pm EST, Monday through Friday. You can also reach Bionpharma by email at drugsafety@bionpharma.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock included in the recall.
- Notify facilities of recalled batches that they have already or will receive.
- If you have questions, contact Bionpharma at (888) 235-2466. They are available from 9:00 a.m. to 5:00 pm EST, Monday through Friday. You can also reach Bionpharma by email at drugsafety@bionpharma.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and consider removing stock included in the warning.
- Notify facilities of recalled batches that they have already or will receive.
- If you have questions, contact Bionpharma at (888) 235-2466. They are available from 9:00 a.m. to 5:00 pm EST, Monday through Friday. You can also reach Bionpharma by email at drugsafety@bionpharma.com.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!
