CLASS II Drug recall · Reported 22 Jul 2015 · FDA Enforcement Report
Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2) recalled
Kremers Urban Pharmaceuticals is recalling Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems, distributed nationwide in the US. The recall was initiated on 7 Jul 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1237-2015
- FDA event ID
- 71656
- Recalling firm
- Kremers Urban Pharmaceuticals, Seymour, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2015
- FDA classified
- 14 Jul 2015
- Reported
- 22 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 Jul 2015 | Recall initiated by company | |
| 14 Jul 2015 | Classified by FDA | +7 days |
| 22 Jul 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 62175-124-01
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Which lots are affected?
Lot #: 5267504, Exp 07/2015
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2) recalled | Kremers Urban Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Kremers Urban Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2) recalled | Kremers Urban Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, USP, 20 mg recalledOmeprazole | Kremers Urban Pharmaceuticals | Other | KY, TN |
Other Nitroglycerin Transdermal System recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2) recalled | Kremers Urban Pharmaceuticals | Potency & Assay | Nationwide |