Drug 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.
D-0772-2021
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 88220
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,692 bottles
- Official record key
drug-enforcement:D-0772-2021
Official wording
Reason: Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Code information: Batch # 16653A, 16654A, Exp 12/2022
Distribution pattern: Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Derived failure modes
-
Unknown
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.