MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by:...
FDA Recall #D-0509-2016 — Class III — November 25, 2015
Product Description
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.
Recalling Firm
Golden State Medical Supply Inc. — Camarillo, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1136 Bottles
Distribution
U.S. Nationwide
Code Information
Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry: Feb-18; Lot #: GS009055, Expiry: Feb-18; Lot #: GS009131; Expiry: Feb-18.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated