Recalls / Class I
Class ID-0444-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot: AW0221A Exp. 08/30/2025
Why it was recalled
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Recalling firm
- Firm
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 153 cartons
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2024-03-28
- FDA classified
- 2024-04-16
- Posted by FDA
- 2024-04-24
- Terminated
- 2024-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0444-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.