Drug product

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.

D-0394-2021

May 20, 2021

Class II

Product summary

Firm: Noven Pharmaceuticals Inc
Event: Event 87980
Status: Ongoing
Classification: Class II
Quantity: 6,689 boxes
Official record key: drug-enforcement:D-0394-2021

Official wording

Reason: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Code information: Lot: 88530 Exp. 10/2021

Distribution pattern: Nationwide in the USA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.