FDA-Drug2014-04-09Class II
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
American Health Packaging
Hazard
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Sold states
Nationwide
Affected count
14,665 blister packs
Manufactured in
2550 John Glenn Ave, Suite A, Columbus, OH, United States
Products
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1188-2014Don't want to check this manually?
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