FDAFDA · Food and drugs·Recall number D-1030-2014
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
Published January 29, 2014 · Recall initiated: December 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROXYZINE HYDROCHLORIDE
- Manufacturer
- KVK-Tech, Inc.
- Distributor
- Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
- UPC
- 0310702012103
- Lot
- lot #11434, exp. Nov-14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.