Why it was recalled
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Product description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Lot numbers, UPCs & expiration codes
Lot: 88530 Exp. 10/2021
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-0394-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 20, 2021
- FDA report date
- Jun 2, 2021
- Quantity
- 6,689 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0394-2021, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 87980
- Address
- 11960 Sw 144th St
- Code information
- Lot: 88530 Exp. 10/2021
- Postal code
- 33186-6109
- Report date
- Jun 2, 2021
- Product type
- Drugs
- Recall number
- D-0394-2021
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals Inc
- Product quantity
- 6,689 boxes
- Reason for recall
- Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 20, 2021
- Initial firm notification
- Letter
- Center classification date
- May 24, 2021