FDA-Drug2014-01-29Class II
HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.
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
249,096 bottles
Manufactured in
110 Terry Dr, Suite 200, Newtown, PA, United States
Products
HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1031-2014Don't want to check this manually?
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