Why it was recalled
Defective Delivery System: Out of specification for adhesive transfer.
Product description
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Lot numbers, UPCs & expiration codes
Lot #: 82237 Exp. May 31, 2018
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-0627-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 9, 2018
- FDA report date
- Apr 25, 2018
- Quantity
- 9016 boxes of 30 patch each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0627-2018, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 79781
- Address
- 11960 SW 144th St
- Code information
- Lot #: 82237 Exp. May 31, 2018
- Postal code
- 33186-6109
- Report date
- Apr 25, 2018
- Product type
- Drugs
- Recall number
- D-0627-2018
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 9016 boxes of 30 patch each
- Termination date
- Jan 24, 2020
- Reason for recall
- Defective Delivery System: Out of specification for adhesive transfer.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2018