FDA Drug Critical Class I Terminated

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.

Reported: September 1, 2021 Initiated: July 2, 2021 #D-0772-2021

Product Description

Reason for Recall

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

Details

Recalling Firm: KVK-Tech, Inc.
Units Affected: 1,692 bottles
Distribution: Product was distributed to one distributor who may have further distributed Nationwide in the USA.
Location: Newtown, PA

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by KVK-Tech, Inc.. Units affected: 1,692 bottles.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on September 1, 2021. Severity: Critical. Recall number: D-0772-2021.