Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.
Reported: May 8, 2013 Initiated: January 31, 2013 #D-312-2013
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.
Reason for Recall
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.
Details
- Recalling Firm
- Noven Pharmaceuticals, Inc.
- Units Affected
- 335,910 patches
- Distribution
- Nationwide and Puerto Rico.
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 335,910 patches.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 8, 2013. Severity: Moderate. Recall number: D-312-2013.
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