Atovaquone Suspension
FDA Recall NDC 69452-252
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Atovaquone (NDC 69452-252). A significant event, classified as Class I, was initiated on Sep 17, 2024 by Bionpharma Inc.. The reported reason for this action was: "Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2024 Class I Recall: Microbial Contamination of a Non-sterile Product
Recall Number
Class I Terminated
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Sep 17, 2024
Oct 23, 2024
1,980 bottles
Recall Profile & Regulatory Data
Event ID
95345
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Bionpharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A.
Termination Date
Sep 16, 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.
Batch or Lot Expiration Information
Lot# 2310083, Exp. 09/30/2025
Affected Packages Involved in this Recall
69452-252-87Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
