Drug recall D-1030-2014
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.
Lots and codes
lot #11434, exp. Nov-14
Recall details
- Recalling firm
- KVK-Tech, Inc., Newtown, PA
- Quantity
- 14664 bottles
- Distribution
- Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 11, 2013
- Terminated
- August 3, 2015
Related products
- Hydroxyzine Hydrochloride – drug information
- NDC 10702-012 Hydroxyzine Hydrochloride · Hydroxyzine Dihydrochloride 50 mg/1 · KVK-Tech, Inc.
- NDC 10702-011 Hydroxyzine Hydrochloride · Hydroxyzine Dihydrochloride 25 mg/1 · KVK-Tech, Inc.
- NDC 10702-010 Hydroxyzine Hydrochloride · Hydroxyzine Dihydrochloride 10 mg/1 · KVK-Tech, Inc.