FDA-Drug2015-11-25Class III
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Par Pharmaceutical Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Sold states
U.S. Nationwide including Puerto Rico
Affected count
a) 387,100 Bottles; b) 63,572 Bottles
Manufactured in
1 Ram Ridge Rd, N/A, Spring Valley, NY, United States
Products
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0234-2016Don't want to check this manually?
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