D-0012-2025 Class I Terminated
FDA drug recall D-0012-2025 was initiated by Bionpharma Inc. on September 17, 2024 and is designated Class I. Reason for recall: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. The recall status is terminated (terminated September 16, 2025). Affected quantity: 1,980 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2024
- Initiation Date
- September 17, 2024
- Termination Date
- September 16, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,980 bottles
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.
Distribution Pattern
Nationwide in the U.S.A.
Code Information
Lot # 2310083, Exp. 09/30/2025