PlainRecalls
FDA Drug Critical Class I Terminated

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Reported: October 23, 2024 Initiated: September 17, 2024 #D-0012-2025

Product Description

Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Reason for Recall

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

Details

Recalling Firm
Bionpharma Inc.
Units Affected
1,980 bottles
Distribution
Nationwide in the U.S.A.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.. Recalled by Bionpharma Inc.. Units affected: 1,980 bottles.
Why was this product recalled?
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 23, 2024. Severity: Critical. Recall number: D-0012-2025.