Par Pharmaceutical Inc. recalls Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bot
Recalled November 25, 2015 · FDA recall D-0234-2016 · Par Pharmaceutical
Hazard
Failed Impurities/Degradation Specifications: Out of specification for impurities. · FDA Class III
Units
a) 387,100 Bottles; b) 63,572 Bottles
Sold at
U.S. Nationwide including Puerto Rico
Description
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Product
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Manufacturer(s)
Par Pharmaceutical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →