FDA recall D-0012-2025

Bionpharma Inc. · Class I · drug

Product

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.

Distribution

Nationwide in the U.S.A.

Key facts

Status
Terminated
Initiation date
2024-09-17
Report date
2024-10-23
Termination date
2025-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2025