Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Pack...
FDA Recall #D-0235-2016 — Class III — November 2, 2015
Product Description
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recalling Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) — Rockford, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,609 Packages
Distribution
US Nationwide including Puerto Rico
Code Information
Lot #: 3060153, Expiry: 08/31/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated