Atovaquone Oral Suspension recall: Sterility Concern
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Why was Atovaquone Oral Suspension recalled?
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 2310083, Exp. 09/30/2025
- 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.
- Recalling firm
- Bionpharma Inc.
- Quantity
- 1,980 bottles
- Distribution
- Nationwide in the U.S.A.
- Recall date
- October 23, 2024
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)