Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma I...
FDA Recall #D-0012-2025 — Class I — September 17, 2024
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.
Recalling Firm
Bionpharma Inc. — Princeton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1,980 bottles
Distribution
Nationwide in the U.S.A.
Code Information
Lot # 2310083, Exp. 09/30/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated