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.
Recall initiated: 20131211
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated