Akorn Voluntarily Recalls Select Lots of Hydroxyzine HClBy
Akorn Inc., a pharmaceutical company based in Lake Forest, Illinois, has initiated a voluntary recall of select lots of hydroxyzine hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, prescription only. The drug was manufactured by Hi-Tech Pharmacal Co., Inc. of Amityville, New York.
The Class II recall was initiated in April 2015 and reported in the US Food and Drug Administrations’ Weekly Enforcement Report of June 17, 2015. The recall was initiated due to failed impurities/degradation specifications. The ongoing recall is nationwide, including Puerto Rico.
One recall applies to 424,174 bottles of hydroxyzine hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, prescription only, manufactured for KVK-Tech, Inc., Newtown, Pennsylvania by Hi-Tech Pharmacal Co., Inc., Amityville, New York, and another recall of additional lots manufactured b Hi-Tech Pharmacal.
A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Source: FDA (as noted above).