FDA recall D-0510-2016

Golden State Medical Supply Inc. · Class III · drug

Product

MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.

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-0510-2016