Akorn, Inc. recalls Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech,
Recalled June 17, 2015 · FDA recall D-1129-2015 · Akorn
Hazard
Failed Impurities/Degradation Specifications · FDA Class II
Units
424,174 bottles
Sold at
Nationwide including Puerto Rico
Description
Failed Impurities/Degradation Specifications
Product
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →