Why it was recalled
Defective Delivery System: One lot exceeded the mechanical peel specification
Product description
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
Lot numbers, UPCs & expiration codes
Lot # 73346, Exp 03/2015
Where it was sold
Nationwide
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-1086-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 12, 2015
- FDA report date
- Jun 3, 2015
- Quantity
- 125,340 Patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1086-2015, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 71201
- Address
- 11960 Sw 144th St
- Code information
- Lot # 73346, Exp 03/2015
- Postal code
- 33186-6109
- Report date
- Jun 3, 2015
- Product type
- Drugs
- Recall number
- D-1086-2015
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 125,340 Patches
- Termination date
- Mar 19, 2019
- Reason for recall
- Defective Delivery System: One lot exceeded the mechanical peel specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 12, 2015
- Initial firm notification
- Letter
- Center classification date
- May 28, 2015