Why it was recalled
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 5267504, Exp 07/2015
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1237-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 7, 2015
- FDA report date
- Jul 22, 2015
- Quantity
- 16,504 Boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kremers Urban Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1237-2015, exactly as published.
Show all FDA fields
- City
- Seymour
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 71656
- Address
- 1101 C Ave W
- Code information
- Lot #: 5267504, Exp 07/2015
- Postal code
- 47274-3342
- Report date
- Jul 22, 2015
- Product type
- Drugs
- Recall number
- D-1237-2015
- Classification
- Class II
- Recalling firm
- Kremers Urban Pharmaceuticals, Inc.
- Product quantity
- 16,504 Boxes
- Termination date
- Feb 12, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 7, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2015