Why it was recalled
Defective Delivery System: Out of specification for mechanical peel.
Product description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, 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
Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021.
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-0294-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 19, 2021
- FDA report date
- Mar 10, 2021
- Quantity
- 551,670 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0294-2021, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 87373
- Address
- 11960 Sw 144th St
- Code information
- Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021.
- Postal code
- 33186-6109
- Report date
- Mar 10, 2021
- Product type
- Drugs
- Recall number
- D-0294-2021
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals Inc
- Product quantity
- 551,670 patches
- Termination date
- Jul 5, 2024
- Reason for recall
- Defective Delivery System: Out of specification for mechanical peel.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, 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
- Feb 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2021