HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
Recall Number: D-1030-2014
Firm: KVK-Tech, Inc.
Classification: Class II
Status: Terminated
Report Date: 20140129
Initiation Date: 20131211
Termination Date: 20150803
Reason for Recall
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Product Description
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.