Product: HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC,  Newtown, PA 18940.  100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.
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