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.
Reported: January 18, 2017 Initiated: August 22, 2016 #D-0430-2017
Product Description
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.
Reason for Recall
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Details
- Recalling Firm
- Noven Pharmaceuticals, Inc.
- Units Affected
- 357,420 patches
- Distribution
- Nationwide within the US
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 357,420 patches.
Why was this product recalled? ▼
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 18, 2017. Severity: Moderate. Recall number: D-0430-2017.
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