Atovaquone Oral Suspension recalled over sterility concerns

Recall date

September 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bionpharma Inc. recalls Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 085…

Recall number

D-0012-2025

FDA classification

Class I

Brand / firm

Bionpharma Inc.

Sold / distributed

Nationwide in the U.S.A.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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.