AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination
- Date
- Apr 1, 2024
- Company
- AvKARE, LLC
- Brand
- AVpak
- Product
- Atovaquone Oral Suspension, USP 750mg/5mL
- Reason
- Potential Bacillus cereus contamination
- Hazard
- Other
- UPC
- 5026808612
- Source
- FDA
How to identify the product
- 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.
- Atovaquone Oral Suspension, USP was distributed between 03/18/2024 through 03/21/2024 Nationwide to Wholesalers.
- 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.
- Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC.
- Consumers that have product which is being recalled should stop using the product and return it to place of purchase or discard.
Where to find the lot number or date code on your package →
Product photos are on the official FDA page.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.