Home / Recalls / Noven Therapeutics, LLC / D-1043-2020

D-1043-2020 Class II Terminated

Recalled by Noven Therapeutics, LLC — Miami, FL

Recall Details

Product Type
Drugs
Report Date
March 25, 2020
Initiation Date
March 2, 2020
Termination Date
May 18, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13761 boxes

Product Description

Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3

Reason for Recall

Defective Delivery System: Out of specification for mechanical peel and shear.

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot#: 85942, Exp 03/2020; 86281, Exp 06/2020

Other recalls by Noven Therapeutics, LLC

  • D-1248-2020 Class II — Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 m (March 31, 2020)
  • D-1249-2020 Class II — Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 m (March 31, 2020)
  • D-1247-2020 Class II — Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 m (March 31, 2020)
  • D-1045-2020 Class II — Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hou (March 2, 2020)
  • D-1044-2020 Class II — Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hou (March 2, 2020)
  • D-1042-2020 Class II — Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hou (March 2, 2020)