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Safety Report: Bionpharma Atovaquone Oral Suspension - recalled due to Cohnella bacteria, United States

1 day ago •source fda.gov

Recall notice

Bionpharma Atovaquone Oral Suspension - recalled due to Cohnella bacteria photo #1

United States

Bionpharma Inc. is voluntarily recalling (1) a single batch of Atovaquone Oral Suspension at the consumer level. The product was found to be contaminated with Cohnella bacteria. 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.

This product recalled is a quinone antimicrobial drug indicated for the prevention of pneumocystis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older. The recall includes the following product and batch number:
- Product Name: Atovaquone Oral Suspension, Production Date: October 26, 2023, Release Date: December 05, 2023, NDC: 69452-252-87, Lot No.: 2310083, Expiration Date: September 2025.
The product can be identified by the HDPE white bottle. The lot number can be obtained from the side panel of the bottle or the bottom flap of the carton.

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 who have the affected lot of the product should stop using the product and return to the place of purchase

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Bionpharma Inc.
Brand name: BionPharma
Product recalled: Atovaquone Oral Suspension, 750 mg/mL
Reason for the recall: The product found to be contaminated with Cohnella bacteria
FDA Recall date: September 18, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial

#recall #drugs #us

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