Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic B...
FDA Recall #D-1074-2014 — Class II — December 18, 2013
Product Description
Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (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
1,249,700 tablets
Distribution
Nationwide
Code Information
lot #14071112AA; Exp. 03/14. lot #14071112AB; Exp. 03/14. lot # 14071012BA; Exp. 03/14. lot #14071012BB; Exp 03/14.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated