Home / Recalls / Noven Pharmaceuticals, Inc. / D-0627-2018

D-0627-2018 Class II Terminated

Recalled by Noven Pharmaceuticals, Inc. — Miami, FL

Recall Details

Product Type
Drugs
Report Date
April 25, 2018
Initiation Date
April 9, 2018
Termination Date
January 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9016 boxes of 30 patch each

Product Description

Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857

Reason for Recall

Defective Delivery System: Out of specification for adhesive transfer.

Distribution Pattern

Nationwide.

Code Information

Lot #: 82237 Exp. May 31, 2018

Other recalls by Noven Pharmaceuticals, Inc.

  • D-0055-2025 Class II — Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hou (October 31, 2024)
  • D-0473-2023 Class II — Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx on (March 10, 2023)
  • D-0472-2023 Class II — Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx onl (March 10, 2023)
  • D-0471-2023 Class II — Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx on (March 10, 2023)
  • D-0470-2023 Class II — Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx onl (March 10, 2023)
  • D-0071-2023 Class II — Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 (November 16, 2022)
  • D-1169-2022 Class II — Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 m (June 24, 2022)
  • D-0889-2022 Class II — Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 m (May 6, 2022)
  • D-0724-2021 Class II — Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per (July 30, 2021)
  • D-0725-2021 Class II — Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per (July 30, 2021)