Class II · Moderate risk
Nitroglycerin injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Nitroglycerin Transdermal System 0.4 mg/hr
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
62175-0124-01
Compare with the code on your package — it is the most precise check available.
Drug: Nitroglycerin
- Recalling firm
- Kremers Urban Pharmaceuticals, Inc.
- NDC code
- 62175-124-01
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1237-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nitroglycerin recalls
See all
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.3MG
CGMP Deviations
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
CGMP Deviations
Class II · Moderate risk
Nitrostat (Nitroglycerin Sublingual Tablets, USP)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Nitroglycerin Lingual Spray
Defective Delivery System
Other recalls by Kremers Urban Pharmaceuticals, Inc.
All 2015 recalls
Class II · Moderate risk
Nitroglycerin Transdermal System 0.2 mg/hr
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
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