Recalls / Class II
Class IID-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.
- 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
- lot #11434, exp. Nov-14
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
- 14664 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-1030-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.