KVK-Tech, Inc.: Drug Recall
Recall #D-0772-2021 · 07/02/2021
Class I: Dangerous
Recall Details
- Recall Number
- D-0772-2021
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- KVK-Tech, Inc.
- Status
- Terminated
- Date Initiated
- 07/02/2021
- Location
- Newtown, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,692 bottles
Reason for Recall
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Product Description
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.
Distribution Pattern
Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Other Recalls by KVK-Tech, Inc.
- Class II: Risk 05/09/2025
- Class II: Risk 05/09/2025
- Class I: Dangerous 09/20/2023
- Class III: Low Risk 04/27/2021
- Class III: Low Risk 12/18/2020
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.