drugs Class II Updated 2012-06-20

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 43783, Exp 01/12
View official government recall

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