Why it was recalled
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Product description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
Lot numbers, UPCs & expiration codes
Lot: 80431 Exp. 08/17
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-1170-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 30, 2017
- FDA report date
- Sep 27, 2017
- Quantity
- 182,850 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1170-2017, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78021
- Address
- 11960 SW 144th St
- Code information
- Lot: 80431 Exp. 08/17
- Postal code
- 33186-6109
- Report date
- Sep 27, 2017
- Product type
- Drugs
- Recall number
- D-1170-2017
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 182,850 patches
- Termination date
- Jan 24, 2020
- Reason for recall
- Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 30, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 18, 2017