FDA-Drug2014-01-29Class II
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
KVK-Tech, Inc.
Hazard
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Sold states
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Affected count
14664 bottles
Manufactured in
110 Terry Dr, Suite 200, Newtown, PA, United States
Products
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1030-2014Don't want to check this manually?
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