Recall: D-1030-2014

Class II - Potentially Harmful

Class IIClassification

2013-12-11Initiated

TerminatedStatus

KVK-Tech, Inc.Firm

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

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.