Recalls / Class II
Class IID-0472-2023
Product
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.
- Brand name
- Daytrana
- Generic name
- Methylphenidate
- Active ingredient
- Methylphenidate
- Route
- Transdermal
- NDCs
- 68968-5552, 68968-5553, 68968-5554, 68968-5555
- FDA application
- NDA021514
- Affected lot / code info
- Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
Why it was recalled
Defective Delivery System: Out of specification for shear.
Recalling firm
- Firm
- Noven Pharmaceuticals Inc
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2023-03-10
- FDA classified
- 2023-03-20
- Posted by FDA
- 2023-03-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0472-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.