The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1236-2015·Announced 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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly identifies this as an FDA Class II recall. According to the severity rubric, FDA Class II recalls are classified as 'Severe' (Score 4), particularly when involving significant potential health risks or structural defects, even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

Kremers Urban Pharmaceuticals, Inc. is recalling Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2) patches. The recall involves 16,832 boxes of the prescription-only medication, identified by Lot # 5267605 and an expiration date of 08/2015. The product was distributed nationwide and in Puerto Rico.

The recall was initiated because the product failed a 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 violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the recalled patches and contact their pharmacist or healthcare provider for guidance on alternative treatments. The recalling firm is responsible for managing the recall and providing further information to affected parties.

The recalled product

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…
Manufacturer
Kremers Urban Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
16,832

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 #: 5267605
  • Exp 08/2015

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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