FDA Drug recall 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…
- FDA Drug
- Class I
- terminated
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class I recall of 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… by Avkare, citing microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0444-2024 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2024-03-28 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
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
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Identifiers
| code_info | Lot: AW0221A Exp. 08/30/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0444-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.