Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
Reported: April 29, 2020 Initiated: March 31, 2020 #D-1248-2020
Product Description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
Reason for Recall
Defective Delivery System: Out of specification for mechanical peel and shear.
Details
- Recalling Firm
- Noven Therapeutics, LLC
- Units Affected
- 5,614 30-count boxes
- Distribution
- Distributed Nationwide in the US
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3. Recalled by Noven Therapeutics, LLC. Units affected: 5,614 30-count boxes.
Why was this product recalled? ▼
Defective Delivery System: Out of specification for mechanical peel and shear.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 29, 2020. Severity: Moderate. Recall number: D-1248-2020.
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