Why it was recalled
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Product description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Lot numbers, UPCs & expiration codes
Lot: 91316 Exp. 02/2023
Where it was sold
Nationwide in the USA
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-0071-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 16, 2022
- FDA report date
- Dec 7, 2022
- Quantity
- 3977 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0071-2023, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 91161
- Address
- 11960 Sw 144th St
- Code information
- Lot: 91316 Exp. 02/2023
- Postal code
- 33186-6109
- Report date
- Dec 7, 2022
- Product type
- Drugs
- Recall number
- D-0071-2023
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals Inc
- Product quantity
- 3977 boxes
- Reason for recall
- Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 16, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 28, 2022