FDA Recall D-0071-2023

Noven Pharmaceuticals Inc · Miami, FL

Class II Ongoing 1275 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), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.

Lot / code: Lot: 91316 Exp. 02/2023

Quantity: 3977 boxes

Reason for recall

Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

Recall record

Recall number: D-0071-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2022-11-16
Classified by FDA Center: 2022-11-28
FDA published: 2022-12-07
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.

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