Noven Pharmaceuticals, Inc.: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Agency Publication Date: July 14, 2016

Affected Products

Product: Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.

Lot #s: 77379, 77380, Exp 05/16; 76944, Exp 03/16

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73718

Status: Resolved

Manufacturer: Noven Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 12285 boxes

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Sources: FDA iRES · Raw API Response

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