FDA recall D-0233-2016

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.

Distribution

U.S. Nationwide including Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-10-26

Report date

2015-11-25

Termination date

2017-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Spring Valley, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0233-2016