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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot: AW0221A Exp. 08/30/2025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AvKARE
- Reason for Recall:
- Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot: AW0221A Exp. 08/30/2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0444-2024
Related Recalls
Failed Content Uniformity Specifications
Class I - Dangerous
Presence of a foreign substance.
Class I - Dangerous
Presence of a foreign substance.