Bionpharma issues nationwide recall of Atovaquone Oral Suspension due to bacterial contamination risks, raising significant health concerns for immunocompromised individuals.
At a Glance
- Bionpharma recalls a specific batch of Atovaquone Oral Suspension.
- The recall is due to potential contamination with Cohnella bacteria.
- The affected product was distributed from December 2023 to June 2024.
- Consumers are urged to stop using and return the product.
Nationwide Recall Due to Contamination
Bionpharma Inc., based in Princeton, New Jersey, is recalling its Atovaquone Oral Suspension (750 mg/mL) over concerns of Cohnella bacteria contamination. Manufactured by CoreRx Inc. in Florida, the affected batch, numbered 2310083, was distributed nationwide between December 2023 and June 2024. No adverse reactions have been reported, but the contaminated product poses significant health risks, especially to immunocompromised individuals.
The FDA has advised consumers to immediately stop using the affected oral suspension and return it to the place of purchase. Exposure to the contaminated product could result in severe and potentially life-threatening infections for those with weakened immune systems. Bionpharma has notified its distributors and customers about the recall and is arranging for the return and replacement of the recalled product.
Product Details and Distribution
The recall applies exclusively to a single batch (2310083) of Atovaquone Oral Suspension, manufactured by CoreRx Inc. in Clearwater, Florida, and distributed by Bionpharma Inc. The product, used for preventing and treating Pneumocystis jiroveci pneumonia (PCP) in individuals aged 13 and older, comes in a white plastic bottle with an expiration date of September 2025.
Consumers can find additional details on FDA.gov, including guidance on returning or safely disposing of the contaminated product. Distributors and retailers have been instructed to halt distribution and remove the affected product from active inventory. Despite the current lack of reported adverse events, vigilance is necessary due to the significant risks posed by potential bacterial contamination.
Health and Safety Implications
The FDA emphasizes that there is a “reasonable probability” the contaminated product could lead to life-threatening infections in immunocompromised patients. Testing revealed the contamination during stability testing conducted by a third-party laboratory. Bacillus cereus contamination poses numerous risks, including severe infections like endocarditis and necrotizing soft tissue infections.
Patients and healthcare providers must stay informed and adhere to the recall instructions, ensuring contaminated products are returned or disposed of properly. For further inquiries, consumers may contact AvKARE at 1-855-361-3993 or via email at [email protected].
Sources:
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial
- https://www.usatoday.com/recalls/food-and-drug/FDA-9awqbp_u_Rs/
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due
- https://www.empr.com/home/news/safety-alerts-and-recalls/possible-microbial-contamination-prompts-recall-of-atovaquone-oral-suspension/
- https://www.theepochtimes.com/us/lung-infection-medication-recalled-nationwide-over-possible-bacterial-contamination-5726721
- https://www.infectioncontroltoday.com/view/atovaquone-oral-suspension-recall-potential-bacillus-cereus-contamination
- https://www.consumeraffairs.com/recalls/bionpharma-inc-recalls-atovaquone-oral-suspension-due-to-bacteria-contamination-091924.html
- https://www.managedhealthcareexecutive.com/view/potential-contamination-leads-to-recall-of-atovaquone
- https://www.contagionlive.com/view/voluntary-recall-of-atovaquone-oral-suspension-due-to-potential-bacillus-cereus-contamination
- https://www.usrecallnews.com/
