Recalls / Class I
Class ID-0772-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.
- Brand name
- Atovaquone Oral Suspension
- Generic name
- Atovaquone
- Active ingredient
- Atovaquone
- Route
- Oral
- NDC
- 10702-223
- FDA application
- ANDA210510
- Affected lot / code info
- Batch # 16653A, 16654A, Exp 12/2022
Why it was recalled
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Recalling firm
- Firm
- KVK-Tech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, N/A, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 1,692 bottles
- Distribution pattern
- Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2021-07-02
- FDA classified
- 2021-08-26
- Posted by FDA
- 2021-09-01
- Terminated
- 2022-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0772-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.