Why it was recalled
Defective Delivery System: Out of specification for mechanical peel and shear.
Product description
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
Lot numbers, UPCs & expiration codes
Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021
Where it was sold
Distributed Nationwide in the US
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-1249-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 31, 2020
- FDA report date
- Apr 29, 2020
- Quantity
- 14,142 30-count boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Therapeutics, LLC
Original FDA data
Every field from FDA enforcement report D-1249-2020, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 85357
- Address
- 11960 Sw 144th St
- Code information
- Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021
- Postal code
- 33186-6109
- Report date
- Apr 29, 2020
- Product type
- Drugs
- Recall number
- D-1249-2020
- Classification
- Class II
- Recalling firm
- Noven Therapeutics, LLC
- Product quantity
- 14,142 30-count boxes
- Termination date
- Jun 17, 2024
- 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) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
- Distribution pattern
- Distributed Nationwide in the US
- Recall initiation date
- Mar 31, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 17, 2020