Drug 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.
D-0444-2024
Product summary
- Firm
- AvKARE
- Event
- Event 94329
- Status
- Terminated
- Classification
- Class I
- Quantity
- 153 cartons
- Official record key
drug-enforcement:D-0444-2024
Official wording
Reason: Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Code information: Lot: AW0221A Exp. 08/30/2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Microbial contamination
Microbial contamination