The Recall Desk

FDA (Drugs) recall action 67141

Teva Pharmaceuticals USA recalled 2 products on 2014-02-12

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-02-12
Critical
0
Units
1,362,500

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 50 mg tablets because they may fail impurity specifications throughout their shelf life.

    Product
    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 Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-02-12

    Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns

    Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 25 mg tablets because they may contain impurities outside of specification limits.

    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).
    Category
    Distribution
    0 states