Recall: D-1031-2014

Class II - Potentially Harmful

Class IIClassification

2013-12-11Initiated

TerminatedStatus

KVK-Tech, Inc.Firm

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

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.