Product: 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.
Recall initiated: 20131218
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated