Why it was recalled
Defective Delivery System: Out of specification for mechanical peel and shear.
Product description
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3
Lot numbers, UPCs & expiration codes
Lot#: 86280, Exp 06/2020
Where it was sold
U.S.A. 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-1042-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 2, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 9513 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Therapeutics, LLC
Original FDA data
Every field from FDA enforcement report D-1042-2020, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 85128
- Address
- 11960 Sw 144th St
- Code information
- Lot#: 86280, Exp 06/2020
- Postal code
- 33186-6109
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1042-2020
- Classification
- Class II
- Recalling firm
- Noven Therapeutics, LLC
- Product quantity
- 9513 boxes
- Termination date
- May 18, 2023
- Reason for recall
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Mar 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 19, 2020