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.

FDA recall notice · announced September 1, 2021 · Kvk-tech

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Reason for recall

Temperature abuse: the firm received customer complaints of unusual grittiness in the product.

Notes

Distribution: Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Lot/code information: Batch # 16653A, 16654A, Exp 12/2022
Quantity: 1,692 bottles
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.