Miami, FL, United States
Noven Pharmaceuticals Inc recalls
12 recalls recorded since 2018, most recently on 31 October 2024. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)7
Terminated or completed5
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 31 October 2024
- Reason
- Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0055-2025
- Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN
Ongoing Class II Drugs
- Recall started
- 10 March 2023
- Reason
- Defective Delivery System: Out of specification for shear.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0473-2023, D-0470-2023, D-0471-2023, D-0472-2023
- Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3
- Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.
- Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3
- Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.
Ongoing Class II Drugs
- Recall started
- 16 November 2022
- Reason
- Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0071-2023
- Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 3
Ongoing Class II Drugs
- Recall started
- 24 June 2022
- Reason
- Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1169-2022
- Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 331
Ongoing Class II Drugs
- Recall started
- 6 May 2022
- Reason
- Defective Delivery System: customer complaints exceeded respective action limits.
- Distribution
- Nationwide to the U.S. Market
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0889-2022
- Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 3
Ongoing Class II Drugs
- Recall started
- 30 July 2021
- Reason
- Failed Stability Specifications; out of specification for shear.
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0724-2021, D-0725-2021
- Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami,
- Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami,
Ongoing Class II Drugs
- Recall started
- 20 May 2021
- Reason
- Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0393-2021, D-0394-2021
- Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By No
- Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By No
Terminated Class II Drugs
- Recall started
- 16 April 2021
- Terminated
- 11 October 2024
- Reason
- Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0337-2021, D-0336-2021
- Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8
- Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
Terminated Class II Drugs
- Recall started
- 19 February 2021
- Terminated
- 5 July 2024
- Reason
- Defective Delivery System: Out of specification for mechanical peel.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0296-2021, D-0294-2021, D-0293-2021, D-0295-2021
- Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC
- Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics
- Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, L
- Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC,
Terminated Class II Drugs
- Recall started
- 7 September 2018
- Terminated
- 9 September 2020
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1209-2018, D-1207-2018, D-1210-2018, D-1208-2018
- Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 6
- Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florid
- Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 6
- Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 3
Terminated Class II Drugs
- Recall started
- 4 May 2018
- Terminated
- 4 June 2020
- Reason
- Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0862-2018, D-0863-2018
- Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by:
- Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist.
Terminated Class II Drugs
- Recall started
- 9 April 2018
- Terminated
- 24 January 2020
- Reason
- Defective Delivery System: Out of specification for adhesive transfer.
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0627-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.