FDA recall D-1031-2014

KVK-Tech, Inc. · Class II · drug

Product

HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.

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-1031-2014