D-0444-2024 Class I Terminated
FDA drug recall D-0444-2024 was initiated by AvKARE on March 28, 2024 and is designated Class I. Reason for recall: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. The recall status is terminated (terminated August 23, 2024). Affected quantity: 153 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2024
- Initiation Date
- March 28, 2024
- Termination Date
- August 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153 cartons
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.
Reason for Recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Distribution Pattern
US Nationwide.
Code Information
Lot: AW0221A Exp. 08/30/2025