Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3

FDA recall notice · announced September 27, 2017 · Noven Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide.
Lot/code information: Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17
Quantity: 331,950 patches
Status: Terminated
Products in this recall event:
- 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, (D-1170-2017)
- 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, (D-1172-2017)
- Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, (D-1169-2017)
- Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, (D-1171-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.