ATOVAQUONE Recall D-0012-2025
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.
ATOVAQUONE Recall D-0012-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0012-2025 |
| Event ID | 95345 |
| Brand | ATOVAQUONE |
| Generic Name | ATOVAQUONE |
| Manufacturer | ATOVAQUONE |
| Original Package? | 1 |
| Active Substance | ATOVAQUONE |
| Drug Route | ORAL |
| Distribution | Nationwide in the U.S.A. |
| Quantity | 1,980 bottles |
| Recall Reason | Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. |
| Drug Classification | Class I |
| Drug Code Info | 20241023 |
| Product NDC | 69452-252 |
| Product NUI | N0000175482 N0000175485 |
| Drug UPC | 0369452252871 |
| Pharma Class (EPC) | Antimalarial [EPC] |
| Recall Initiation Date | 20240917 |
| Report Date | 20241023 |
| Classification Date | 20241015 |
| Address | 400 Alexander Park Ste 2-4b Princeton, NJ 08540-6539 United States |
| Recalling Firm | Bionpharma Inc. |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | Y883P1Z2LT |
| Drug Application Number | ANDA212918 |
| Structured Product Labeling (SPL ID) | 0d5fc0ab-9cfa-0a79-e063-6394a90a2b61 |
| Structured Product Labeling (SPL Set ID) | bff4f4fc-6307-f414-e053-2a95a90ac0de |
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