Bottle of Atovaquone Oral Suspension
Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.
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.
"We take these findings seriously and are taking immediate action to address the situation. We have initiated a recall of the (1) affected batch listed below and are implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process."
This product is a quinone antimicrobial drug indicated for prevention of pneumocycstis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older. The affected batch of product was manufactured at CoreRx, Inc. and shipped nationwide to our customers between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers.
The recall includes the following product and batch number:
Production Date = October 26, 2023
Release Date = December 05, 2023
Product Name = Atovaquone Oral Suspension
NDC = 69452-252-87
Lot No. = 2310083
Expiration Date = September 2025
The lot number can be obtained from the side panel of the bottle or the bottom flap of the carton.
The Company is notifying its distributors and customers by email and is arranging for return/replacement etc. of the recalled batch of the product. Distributors/retailers that have affected lot of the drug product which is being recalled should immediately cease distribution and remove it from active inventory. Consumers that have the affected lot of the product should stop using the product and return to the place of purchase
Similar Atovaquone recall
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Source: FDA
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Consumers with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST) or via email to drugsafety@bionpharma.com. Consumers 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
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.