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.
D-0012-2025
Product summary
- Firm
- Bionpharma Inc.
- Event
- Event 95345
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,980 bottles
- Official record key
drug-enforcement:D-0012-2025
Official wording
Reason: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Code information: Lot # 2310083, Exp. 09/30/2025
Distribution pattern: Nationwide in the U.S.A.
Derived failure modes
-
Microbial contamination
Microbial Contamination