FDANovember 25, 2015drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

golden state medical supplygoldengolden state

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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