Class I Recall

AvKARE

Product
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.
Reason
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Classification
Class I
Status
Terminated
Lot
Lot: AW0221A Exp. 08/30/2025
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.