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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