FDA-Drug2015-12-16Class III
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.
Golden State Medical Supply Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Sold states
U.S. Nationwide
Affected count
a) 737 Bottles; b) 3863 Bottles
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2016Don't want to check this manually?
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