FDA-Drug2014-02-12Class II
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).
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Sold states
Nationwide
Affected count
1,249,700 tablets
Manufactured in
425 Privet Rd, Horsham, PA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1074-2014Don't want to check this manually?
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