Minivelle Film, Extended Release
FDA Recall NDC 68968-6650
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 9 recorded enforcement report(s) associated with Minivelle (NDC 68968-6650). A significant event, classified as Class II, was initiated on Apr 16, 2021 by Noven Therapeutics, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Apr 16, 2021
Apr 28, 2021
12060 cartons
Recall Profile & Regulatory Data
Event ID
87741
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 11, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# : 88584 Exp. 03/2022
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
Class II Terminated
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Sep 07, 2018
Oct 03, 2018
74908 boxes of 8 patches
Recall Profile & Regulatory Data
Event ID
80997
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 09, 2020
Product Description
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 68968-6675-8
Batch or Lot Expiration Information
Lot# Lots: 82599 Exp. 05/2019; 82660 Exp. 03/2019; 83396 Exp. 09/2019
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
Class II Terminated
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Sep 07, 2018
Oct 03, 2018
213714 boxes of 8 patches and 15927 boxes of 2 patches
Recall Profile & Regulatory Data
Event ID
80997
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 09, 2020
Product Description
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, Florida 33186 --- NDC 68968-6610-8
Batch or Lot Expiration Information
Lot# a) 82200 Exp. 01/2019 b) 81637 Exp. 10/2018; 82200 Exp. 01/2019; 82293 Exp. 02/2019; 82600 Exp. 04/2019; 83027 Exp. 04/2019; 83173 Exp. 06/2019; 83396 Exp. 09/2019
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
Class II Terminated
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Sep 07, 2018
Oct 03, 2018
26217 boxes of 8 patches
Recall Profile & Regulatory Data
Event ID
80997
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 09, 2020
Product Description
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 68968-6625-8
Batch or Lot Expiration Information
Lot# Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
Class II Terminated
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Sep 07, 2018
Oct 03, 2018
149631 boxes of 8 patches and 15809 boxes of 2 patches
Recall Profile & Regulatory Data
Event ID
80997
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 09, 2020
Product Description
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 33186 --- NDC 68968-6650-8
Batch or Lot Expiration Information
Lot# a) 82292 Exp. 02/2019; b) 82139 Exp. 10/2018; 82292 Exp. 02/2019; and 82598 Exp. 04/2019
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
Class II Terminated
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.
May 04, 2018
May 16, 2018
61960 boxes
Recall Profile & Regulatory Data
Event ID
80033
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jun 04, 2020
Product Description
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: Noven Therapeutics, LLC, Miami, Florida 33186.
Batch or Lot Expiration Information
Lot# : 81391, 81638 Exp. 10/18
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
68968-6610-1Product
Class II Terminated
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.
May 04, 2018
May 16, 2018
70870 boxes
Recall Profile & Regulatory Data
Event ID
80033
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jun 04, 2020
Product Description
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. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Batch or Lot Expiration Information
Lot# : 81896, Exp. 03/19; 82264 Exp. 12/18
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
68968-6637-1Product
Class III Terminated
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Apr 27, 2017
Jul 05, 2017
14434 cartons
Recall Profile & Regulatory Data
Event ID
77466
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within US
Termination Date
Mar 11, 2019
Product Description
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Batch or Lot Expiration Information
Lot# :: 78618, Exp. 05/2017
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
Class II Terminated
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Feb 25, 2015
Apr 22, 2015
720 transdermal patches
Recall Profile & Regulatory Data
Event ID
70764
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2019
Product Description
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
Batch or Lot Expiration Information
Lot# 76476; Exp 07/16
Affected Packages Involved in this Recall
68968-6625-8Product
68968-6637-8Product
68968-6650-8Product
68968-6675-8Product
68968-6610-8Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
