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 00182-05

FDA recall notice · announced February 12, 2014 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: lot #14071112AA; Exp. 03/14. lot #14071112AB; Exp. 03/14. lot # 14071012BA; Exp. 03/14. lot #14071012BB; Exp 03/14.
Quantity: 1,249,700 tablets
Status: Terminated
Products in this recall event:
- 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 Laborat (D-1075-2014)
- 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, Se (D-1074-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.