Recall archive / FDA company announcement
AVpak: Atovaquone Oral Suspension, USP 750mg/5mL — FDA announcement Apr 1, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Apr 1, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Atovaquone Oral Suspension, USP 750mg/5mL
- Reason
- Potential Bacillus cereus contamination
- Classification
- Not supplied
- Recalling firm
- AvKARE, LLC
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 96ba83b28934370e
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | FOR IMMEDIATE RELEASE – 3/29/2024 –AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.; The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Apr 1, 2024
- Company announcement date
- Apr 1, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.