US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 18, 2013 (13 years ago)

Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

What was recalled

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).

Recalling firm
Teva Pharmaceuticals USA
NDC code
00182-0554-89
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1074-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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