FDA recall D-0772-2021

KVK-Tech, Inc. · Class I · 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.

Reason for recall

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.

Key facts

Status
Terminated
Initiation date
2021-07-02
Report date
2021-09-01
Termination date
2022-05-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0772-2021