Why it was recalled
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Product description
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
Lot numbers, UPCs & expiration codes
Lot # 53995
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-1413-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 22, 2012
- FDA report date
- Jul 18, 2012
- Quantity
- 185,160 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1413-2012, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62002
- Address
- 11960 Sw 144th St
- Code information
- Lot # 53995
- Postal code
- 33186-6109
- Report date
- Jul 18, 2012
- Product type
- Drugs
- Recall number
- D-1413-2012
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 185,160 patches
- Termination date
- May 9, 2014
- Reason for recall
- Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 22, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 12, 2012