Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Reported: December 7, 2022 Initiated: November 16, 2022 #D-0071-2023
Product Description
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
Reason for Recall
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Details
- Recalling Firm
- Noven Pharmaceuticals Inc
- Units Affected
- 3977 boxes
- Distribution
- Nationwide in the USA
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.. Recalled by Noven Pharmaceuticals Inc. Units affected: 3977 boxes.
Why was this product recalled? ▼
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 7, 2022. Severity: Moderate. Recall number: D-0071-2023.
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