Home / Recalls / Noven Pharmaceuticals, Inc. / D-1172-2017

D-1172-2017 Class II Terminated

Recalled by Noven Pharmaceuticals, Inc. — Miami, FL

Recall Details

Product Type
Drugs
Report Date
September 27, 2017
Initiation Date
August 30, 2017
Termination Date
January 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
234,960 patches

Product Description

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

Reason for Recall

Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Distribution Pattern

Nationwide.

Code Information

Lot: 80426 Exp. 10/17

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-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-0473-2023 Class II — Daytrana (methylphenidate transdermal system) CII, 30 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)