Recall: D-0772-2021

Class I - Dangerous

Class IClassification

2021-07-02Initiated

TerminatedStatus

KVK-Tech, Inc.Firm

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

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

Distribution

Product was distributed to one distributor who may have further distributed Nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.