FDAFDA · Food and drugs·Recall number D-1074-2014
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).
Published February 12, 2014 · Recall initiated: December 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide
- Lot
- lot #14071112AA; Exp. 03/14. lot #14071112AB; Exp. 03/14. lot # 14071012BA; Exp. 03/14. lot #14071012BB; Exp 03/14.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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