Class II · Moderate risk Ongoing
Nitroglycerin Sublingual Tablets 0.3MG
Reason CGMP Deviations
Nitroglycerin Transdermal System 0.2 mg/hr
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
What was recalled
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 62175-123-01
- Recalling firm
- Kremers Urban Pharmaceuticals, Inc.
- NDC code
- 62175-123-01
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1236-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Nitroglycerin recalls
See all
Class II · Moderate risk Ongoing
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nitrostat
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Nitroglycerin Lingual Spray
Reason Defective Delivery System
Class II · Moderate risk Terminated
Rectiv
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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