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