Noven Pharmaceuticals, Inc.: Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Agency Publication Date: July 1, 2015

Affected Products

Product: Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.

Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13

Product: Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.

Lot #: 43008, Exp 01/12; 48591, Exp 10/12

Lot Numbers:

43008

Product: Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.

Lot #: 43783, Exp 01/12

Lot Numbers:

43783

Product: Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.

Lot #: 41843, Exp 11/11

Lot Numbers:

41843

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61891

Status: Resolved

Manufacturer: Noven Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 4 products (357,510 patches; 242,100 patches; 244,320 patches; 335,190 patches)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13

Lot #: 43008, Exp 01/12; 48591, Exp 10/12

Lot Numbers:

43008

Lot #: 43783, Exp 01/12

Lot Numbers:

43783

Lot #: 41843, Exp 11/11

Lot Numbers:

41843