FDA recall D-0235-2016

Product

Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.

Reason for recall

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

Distribution

US Nationwide including Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-11-02

Report date

2015-11-25

Termination date

2016-12-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0235-2016