TOPIC: Atovaquone Oral Suspension by Bionpharma: Recall - Due to Bacterial Contamination
AUDIENCE: Patient, Health Professional, Pharmacy, Pulmonology, Infectious Disease
ISSUE: Bionpharma is recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750 mg per mL because the product was found to be contaminated with Cohnella bacteria. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc.
Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue.
To date, Bionpharma has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The recalled product is a quinone antimicrobial drug indicated for prevention of Pneumocystis jirovecii pneumonia (formerly known as PCP for Pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older.
RECOMMENDATIONS:
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Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the affected lot of the drug product.
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Patients that have the affected lot of the product should stop using the product and return to the place of purchase.
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Patients with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 or via email to drugsafety@bionpharma.com.
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Distributors/retailers that have affected lot of the drug product which is being recalled should immediately cease distribution and remove it from active inventory.
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