ATOVAQUONE Recall D-0444-2024
Description: Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
ATOVAQUONE Recall D-0444-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0444-2024 |
| Event ID | 94329 |
| Brand | ATOVAQUONE |
| Generic Name | ATOVAQUONE |
| Manufacturer | ATOVAQUONE |
| Active Substance | ATOVAQUONE |
| Drug Route | ORAL |
| Distribution | US Nationwide. |
| Quantity | 153 cartons |
| Recall Reason | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. |
| Drug Classification | Class I |
| Drug Code Info | 20240424 |
| Product NDC | 50268-086 |
| Product NUI | N0000175482 N0000175485 |
| Pharma Class (EPC) | Antimalarial [EPC] |
| Recall Initiation Date | 20240328 |
| Report Date | 20240424 |
| Classification Date | 20240416 |
| Address | 615 N 1st St Pulaski, TN 38478-2403 United States |
| Recalling Firm | AvKARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | Y883P1Z2LT |
| Drug Application Number | ANDA210692 |
| Structured Product Labeling (SPL ID) | d5cbb80c-c326-ac08-e053-2995a90a264d |
| Structured Product Labeling (SPL Set ID) | a50fb7df-6f2d-63f9-e053-2a95a90ad9d3 |
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