Atovaquone Oral Suspension Recalled for Bacillus cereus Contamination
Camber Pharmaceuticals is recalling Atovaquone Oral Suspension due to contamination by Bacillus cereus bacteria. The contamination was discovered during testing of repackaged medication.
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 FDA Class I recall requires a minimum severity of 4 per regulatory guidelines. The actual detection of Bacillus cereus contamination in a prescription medication justifies the Severe classification despite no reported illnesses.
Plain-English summary
Camber Pharmaceuticals Inc. is recalling Atovaquone Oral Suspension USP (750 mg/5 mL) because testing identified Bacillus cereus contamination in repackaged product. The contaminated lot (E220182, expiring December 31, 2023) includes 1,568 bottles. This is an FDA Class I recall, the agency's most serious classification.
The recalled medication was distributed nationwide in the United States. Patients taking this medication should contact their healthcare provider immediately. Do not continue use of the affected product without consulting a healthcare provider about alternatives.
The recalled product
- Product
- ATOVAQUONE (ATOVAQUONE)
- Brand
- ATOVAQUONE
- Manufacturer
- Camber Pharmaceuticals Inc.
- Category
- Drug — Antimalarial
- Affected units
- 1,568
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# E220182
- Exp. 12/31/2023
UPCs (1)
- 0331722629218
Distribution
Distributed nationwide across the United States.
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