Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination
Company Contact: Drug Safety Department, Bionpharma Inc.
Phone Number: 1-888-235-2466
Email: drugsafety@bionpharma.com
FOR IMMEDIATE RELEASE – September 17, 2024 – Princeton, NJ, 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 | Release Date | Product Name | NDC | Lot No. | Expiration Date |
| October 26, 2023 | December 05, 2023 | Atovaquone Oral Suspension | 69452-252-87 | 2310083 | September 2025 |
The product can be identified by the HDPE white bottle, picture below.
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.
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 either to the company directly or to the FDA’s MedWatch Adverse Event Reporting program.
FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Reporting to Company:
- Via phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST)
- Via email to drugsafety@bionpharma.com.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Recall Faq's
Bionpharma Inc., the distributor of Atovaquone Oral Suspension, has initiated the recall of one single lot of the product (Lot # 2310083; Expiry: 09/2025), and it is being conducted in cooperation with the Food and Drug Administration (FDA).
Lot 2310083 of the product Atovaquone Oral Suspension, manufactured by CoreRx Inc. and supplied by Bionpharma Inc., was found to contain Cohnella bacteria.
The product is manufactured at CoreRx Inc. located in Florida.
At this time, only one lot supplied by Bionpharma Inc. is impacted.
NDC # | Impacted Lot # | Expiry Date |
69452-0252-87 | 2310083 | 09/2025 |
There are no concerns regarding any other lot of the drug product.
The batch was distributed by Bionpharma between December 21, 2023 and June 20, 2024.
The lot number can be obtained from the side panel of the bottle or the bottom flap of the carton.
Refer to images below:
Image of the bottle
Image of the carton
If you are a consumer
- If you have any medication from this affected batch/lot remaining, please destroy or discard any remaining product.
- If you are currently taking Atovaquone Oral Suspension 750mg/5mL and Lot No. is 2310083 (affected batch/lot), please stop using the product and contact your Pharmacy for a replacement.
- If you have consumed the product from the affected lot and have experienced or are experiencing any adverse effects, please contact your doctor. Please also call Bionpharma’s drug safety at 1-888-235-BION(2466) or via email at drugsafety@bionpharma.com and report the adverse effects.
- Please contact the pharmacy from where you purchased the product for any refund.
If you are a distributor
- Immediately cease distribution of the drug product from the affected lot (Lot # 2310083) and remove it from active inventory.
- Please promptly return the “Recall Response Form” that Bionpharma representative has sent to you and request a Return Authorization (RA). The RA will contain all information required to return affected lot (Lot 2310083) of Atovaquone Oral Suspension.
- If you do not have a Recall Response Form or Return Authorization, please contact 919-396-5649 (Mon-Fri 9AM-5PM) or via email at returns@bionpharma.com.
- Credit for any returned merchandise, along with shipping charges, will be reimbursed by credit memo.
- If you have supplied the impacted lot to retail pharmacies, please take the following steps:
- Please forward the Recall Letter along with the Recall Response Form to the retailer.
- Instruct the retailer to immediately cease distribution of the drug product from the affected lot (Lot # 2310083) and remove it from active inventory.
- Instruct the retailer to complete the Recall Response Form and send it to Bionpharma (as explained in #b above).
- Please instruct the retailers to contact the customers who may have received the impacted lot and ask them to return any unused product to the pharmacy.
If you are a retail pharmacy
Please follow instructions in (e) above. If you have any questions regarding the return of the recalled product, please contact 919-396-5649 (Mon-Fri 9AM-5PM) or via email at returns@bionpharma.com.
To report any adverse events please call Bionpharma’s drug safety at 1-888-235-BION(2466) or via email at drugsafety@bionpharma.com.
If you are a consumer, please return the product to the pharmacy (place of purchase) for a refund.
If you are a distributor or a pharmacy, please contact 919-396-5649 (Mon-Fri 9AM-5PM) or via email at returns@bionpharma.com.
If you have consumed the product from the affected lot and have experienced or are experiencing any adverse effects, please contact your doctor. Please also call Bionpharma’s drug safety at 1-888-235-BION(2466) or via email at drugsafety@bionpharma.com and report the adverse effects.
People with compromised immune systems are most at risk. If you are concerned, please speak with your doctor.
The recall is being conducted in cooperation with the Food and Drug Administration (FDA).
FDA has classified it as a Class I Recall.
The recall is being conducted to the consumer level.
Please visit to www.bionpharma.com for the official press release.