FDA Recall D-0471-2023
Noven Pharmaceuticals Inc · Miami, FL
Class II Ongoing 1161 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3
Reason for recall
Defective Delivery System: Out of specification for shear.
Recall record
- Recall number
D-0471-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide
- Recall initiated
- 2023-03-10
- Classified by FDA Center
- 2023-03-20
- FDA published
- 2023-03-29
- Recalling firm
- Noven Pharmaceuticals Inc
- Firm location
- Miami, FL
Drug identification
- Brand name(s)
- DAYTRANA
- Generic name(s)
- METHYLPHENIDATE
- Manufacturer(s)
- Noven Therapeutics, LLC
- NDC(s)
68968-5552, 68968-5553, 68968-5554, 68968-5555- Route(s)
- TRANSDERMAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.