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.
Reason for recall: Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recall initiated: 20151026
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated