Par Pharmaceutical Inc. recalls Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct
Recalled November 25, 2015 · FDA recall D-0233-2016 · Par Pharmaceutical
Hazard
Failed Impurities/Degradation Specifications: Out of specification for impurities. · FDA Class III
Units
a) 162,385 Bottles; b) 6949 Bottles
Sold at
U.S. Nationwide including Puerto Rico
Description
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Product
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), 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 →