Atovaquone Oral Suspension Recalled for Temperature Abuse
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which per the rubric requires a minimum severity score of 4. Temperature-induced physical changes to a prescription drug can compromise therapeutic efficacy and safety, warranting a Severe rating.
Plain-English summary
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL, 210 mL bottles) due to temperature abuse during storage or distribution. The firm received customer complaints reporting unusual grittiness in the product.
Batch numbers 16653A and 16654A with expiration dates of 12/2022 are affected. The product was distributed to one distributor who may have further distributed it nationwide in the USA.
Consumers and healthcare providers in possession of this medication should not use it. Patients taking Atovaquone should contact their healthcare provider for guidance on obtaining a replacement or alternative medication. The FDA classifies this as a Class I recall.
The recalled product
- Product
- ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
- Brand
- ATOVAQUONE ORAL SUSPENSION
- Manufacturer
- KVK-Tech, Inc.
- Hazard
- temperature-abuse
- product-degradation
- quality-defect
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 (3)
- Batch # 16653A
- 16654A
- Exp 12/2022
UPCs (1)
- 0310702223219
Distribution
Distributed nationwide across the United States.
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