FDA Recall D-0444-2024
AvKARE · Pulaski, TN
Class I — life-threatening Terminated 148 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 for recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Recall record
- Recall number
D-0444-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2024-03-28
- Classified by FDA Center
- 2024-04-16
- FDA published
- 2024-04-24
- Terminated
- 2024-08-23
- Recalling firm
- AvKARE
- Firm location
- Pulaski, TN