FDA recall D-0509-2016

Product

MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2015-11-25

Report date

2015-12-16

Termination date

2016-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2016