Why it was recalled
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Product description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3
Lot numbers, UPCs & expiration codes
Lot #: 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017.
Where it was sold
Nationwide within the US
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-0428-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2016
- FDA report date
- Jan 18, 2017
- Quantity
- 1,068,600 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0428-2017, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 75450
- Address
- 11960 SW 144th St
- Code information
- Lot #: 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017.
- Postal code
- 33186-6109
- Report date
- Jan 18, 2017
- Product type
- Drugs
- Recall number
- D-0428-2017
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 1,068,600 patches
- Termination date
- Mar 20, 2019
- Reason for recall
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Aug 22, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 10, 2017