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…

Recall date

October 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0233-2016

FDA classification

Class III

Brand / firm

Par Pharmaceutical Inc.

Sold / distributed

U.S. Nationwide including Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.