FDA recall D-1030-2014

KVK-Tech, Inc. · Class II · drug

Product

HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.

Reason for recall

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Distribution

Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.

Key facts

Status
Terminated
Initiation date
2013-12-11
Report date
2014-01-29
Termination date
2015-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newtown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1030-2014