Why it was recalled
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Product description
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Lot numbers, UPCs & expiration codes
Lot #: 75983, Expiry: 11/15
Where it was sold
US 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-0008-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2015
- FDA report date
- Oct 14, 2015
- Quantity
- 125,250 Patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0008-2016, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 72174
- Address
- 11960 SW 144th St
- Code information
- Lot #: 75983, Expiry: 11/15
- Postal code
- 33186-6109
- Report date
- Oct 14, 2015
- Product type
- Drugs
- Recall number
- D-0008-2016
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 125,250 Patches
- Termination date
- Mar 20, 2019
- Reason for recall
- Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
- Distribution pattern
- US Nationwide
- Recall initiation date
- Jul 27, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 6, 2015