FDA recall D-1129-2015

Akorn, Inc. · Class II · drug

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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide including Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-04-07
Report date: 2015-06-17
Termination date: 2017-11-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1129-2015