FDARecalled Apr 24, 2024 · #D-0444-2024
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.
Hazard
Class I — serious health risk
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Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Classification: Class I Distribution: US Nationwide.
Product details
- 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.
- Type
- Drugs
- Manufacturer
- AvKARE
- Model numbers
- AW0221A
- UPCs
- —