Multi-event August 2017 FDA Recall Daytrana by Noven Pharmaceuticals, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Noven Pharmaceuticals, Inc. on August 30, 2017 for the product Daytrana. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1172-2017
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
08-30-2017
09-27-2017
234,960 patches
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot: 80426 Exp. 10/17
Affected Packages Involved in this Recall
Recall Number: D-1169-2017
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
08-30-2017
09-27-2017
321,900 patches
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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, Inc., Miami, FL 33186, NDC# 68968-5552-3
Batch or Lot Expiration Information
Lot# Lot: 80433 Exp. 08/17
Affected Packages Involved in this Recall
Recall Number: D-1171-2017
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
08-30-2017
09-27-2017
331,950 patches
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17
Affected Packages Involved in this Recall
Recall Number: D-1170-2017
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
08-30-2017
09-27-2017
182,850 patches
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
01-24-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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, Inc., Miami, FL 33186, NDC# 68968-5554-3
Batch or Lot Expiration Information
Lot# Lot: 80431 Exp. 08/17
