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.
Recall Number: D-0444-2024
Firm: AvKARE
Classification: Class I
Status: Terminated
Report Date: 20240424
Initiation Date: 20240328
Termination Date: 20240823
Reason for Recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Product 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.