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Daytrana 20mg Patch (Noven) – Delivery System Defect (2014)

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

Class IIModerate

FDAFeb 13, 2014Nationwide• Noven Pharmaceuticals, Inc.

Daytrana 30mg Patch (Noven) – Delivery System Defect (2014)

Class IIModerate

FDA

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Daytrana 20mg Patch (Noven) – Delivery System Defect (2014)

Daytrana 30mg Patch (Noven) – Delivery System Defect (2014)

Fluoxetine 20mg Capsules (Teva) – Odor Contamination (2014)

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