Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
Reported: September 27, 2017 Initiated: August 30, 2017 #D-1170-2017
Product Description
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3
Reason for Recall
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Details
- Recalling Firm
- Noven Pharmaceuticals, Inc.
- Units Affected
- 182,850 patches
- Distribution
- Nationwide.
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5554-3. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 182,850 patches.
Why was this product recalled? ▼
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 27, 2017. Severity: Moderate. Recall number: D-1170-2017.
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