Why it was recalled
Defective Delivery System: Out of specification for shear.
Product description
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.
Lot numbers, UPCs & expiration codes
Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
Where it was sold
US 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-0472-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 10, 2023
- FDA report date
- Mar 29, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0472-2023, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 91882
- Address
- 11960 Sw 144th St
- Code information
- Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
- Postal code
- 33186-6109
- Report date
- Mar 29, 2023
- Product type
- Drugs
- Recall number
- D-0472-2023
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals Inc
- Reason for recall
- Defective Delivery System: Out of specification for shear.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.
- Distribution pattern
- US Nationwide
- Recall initiation date
- Mar 10, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 20, 2023