Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
Recall Number: D-1130-2015
Firm: Akorn, Inc.
Classification: Class II
Status: Terminated
Report Date: 20150617
Initiation Date: 20150407
Termination Date: 20171129
Reason for Recall
Failed Impurities/Degradation Specifications
Product Description
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16