The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1237-2015·Announced 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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or hospitalizations, as the hazard is a potential impurity failure rather than a confirmed acute health threat.

Plain-English summary

Kremers Urban Pharmaceuticals, Inc. is recalling 16,504 boxes of Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2). The product is a prescription-only medication manufactured by LTS Lohmann Therapie Systeme AG. The affected lot number is 5267504, with an expiration date of 07/2015.

The recall was initiated because two lots failed specification for an unknown impurity during 24-month stability testing. This is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.

The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

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…
Manufacturer
Kremers Urban Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
16,504

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 5267504
  • Exp 07/2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Kremers Urban Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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