Recalls / Class II
Class IID-1032-2014
Product
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.
- Brand name
- Hydroxyzine Hydrochloride
- Generic name
- Hydroxyzine Hydrochloride
- Active ingredient
- Hydroxyzine Dihydrochloride
- Route
- Oral
- NDCs
- 10702-010, 10702-011, 10702-012
- FDA application
- ANDA040786
- Affected lot / code info
- NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; lot #10693, exp. Jul-14; lot #10854, Jul-14; lot # 10942, exp. Sep-14; lot #10995, exp.Oct-14; lot # 10996, Nov-14; lot #11138, exp. Feb-15; lot # 11139 Feb-15; lot # 11140, exp. Feb-15; lot # 11445, exp. Nov-15. NDC: 10702-012-10: lot # 10679, exp. Jan-14; lot # 10689, exp. Jun-14; lot # 10941, Sep-14; lot #10997; Nov-14; lot #10998, Nov-14; lot # 10999, Nov-14; lot #11445, exp. Nov-15. NDC: 10702-012-50: lot #10678, exp. Jan-14; lot #10689, exp. Jun-14; lot #10855, exp. Jul-14; lot # 10943, exp. Sep-14; lot # 11136, exp. Feb-15; lot #11137, exp. Feb-15; lot# 11445, exp. Nov-15.
Why it was recalled
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Recalling firm
- Firm
- KVK-Tech, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, Suite 200, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 104551 bottles
- Distribution pattern
- Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Timeline
- Recall initiated
- 2013-12-11
- FDA classified
- 2014-01-22
- Posted by FDA
- 2014-01-29
- Terminated
- 2015-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1032-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.