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.

FDA recall notice · announced April 24, 2024 · Avkare

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: US Nationwide.
Lot/code information: Lot: AW0221A Exp. 08/30/2025
Quantity: 153 cartons
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.