Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech R...
FDA Recall #D-1075-2014 — Class II — December 18, 2013
Product Description
Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister).
Reason for Recall
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Recalling Firm
Teva Pharmaceuticals USA — Horsham, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
112,800 tablets
Distribution
Nationwide
Code Information
Lot # 6A201018VA; Exp. 01/14.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated