FDA recall D-1188-2014

American Health Packaging · Class II · drug

Product

HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01

Reason for recall

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-01-31
Report date
2014-04-09
Termination date
2015-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1188-2014