The Recall Desk

FDA (Drugs) recall action 71656

Kremers Urban Pharmaceuticals, Inc. recalled 2 products on 2015-07-22

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
2015-07-22
Critical
0
Units
33,336

Why these products were recalled

Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.

Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.

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.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2015-07-22

    Kremers Urban Recalls Nitroglycerin Transdermal Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling 16,504 boxes of Nitroglycerin Transdermal Systems because two lots failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2015-07-22

    Kremers Urban Recalls Nitroglycerin Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling Nitroglycerin Transdermal Systems because they failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Distribution
    1 state