Atovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination
Bionpharma Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL) nationwide due to Cohnella bacteria contamination. The recall affects 1,980 bottles.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I drug recall for bacterial contamination of a non-sterile pharmaceutical product. FDA Class I classification mandates a minimum severity score of 4. No illnesses or injuries have been reported.
Plain-English summary
Bionpharma Inc. is recalling Atovaquone Oral Suspension, USP 750 mg/5 mL in 210 mL bottles due to contamination with Cohnella bacteria. The affected product has lot number 2310083 with an expiration date of 09/30/2025.
Atovaquone is a non-sterile prescription oral suspension used as an antimalarial and antiprotozoal medication. The contamination poses a potential risk to consumers using this product.
The recalled product consists of 1,980 bottles that were distributed nationwide in the United States. Consumers who have obtained this medication should contact their healthcare provider or pharmacy for guidance.
The recalled product
- Product
- ATOVAQUONE (ATOVAQUONE)
- Brand
- ATOVAQUONE
- Manufacturer
- Bionpharma Inc.
- Category
- Drug — Oral Suspension
- Affected units
- 1,980
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 2310083
- Exp. 09/30/2025
UPCs (1)
- 0369452252871
Distribution
Distributed nationwide across the United States.
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