Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 0854
Summary
The FDA issued a Class I for Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by Bionpharma Inc.. Reason: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria..
Details
Source
Drug Recall
External ID
D-0012-2025
Action Date
2024-10-23
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot # 2310083, Exp. 09/30/2025
Quantity Affected: 1,980 bottles
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-17
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 18 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bionpharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bionpharma Inc. have FDA actions?
This is the only FDA action we have on record for Bionpharma Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0012-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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