NDC 68968-6675
Minivelle 0.075 mg per 1 d film, extended release
On the label: Noven Therapeutics, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Noven Pharmaceuticals, Inc. | Miami, FL, United States | Makes it | Problems found, fixed voluntarilyAug 24, 2026 · 11 inspections, 2 with FDA action |
Recalls
- Apr 16, 2021 · Class II · Noven Pharmaceuticals Inc
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.
Lots: Lot #: 88584 Exp. 03/2022 - Sep 7, 2018 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Lots: 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 - Sep 7, 2018 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Lots: a) 82292 Exp. 02/2019; b) 82139 Exp. 10/2018; 82292 Exp. 02/2019; and 82598 Exp. 04/2019 - Sep 7, 2018 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Lots: Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019 - Sep 7, 2018 · Class II · Noven Pharmaceuticals, Inc.
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Lots: Lots: 82599 Exp. 05/2019; 82660 Exp. 03/2019; 83396 Exp. 09/2019 - May 4, 2018 · Class II · Noven Pharmaceuticals, Inc.
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.
Lots: Lot #: 81391, 81638 Exp. 10/18 - May 4, 2018 · Class II · Noven Pharmaceuticals, Inc.
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.
Lots: Lot #: 81896, Exp. 03/19; 82264 Exp. 12/18 - Apr 27, 2017 · Class III · Noven Pharmaceuticals, Inc.
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Lots: Lot #:: 78618, Exp. 05/2017 - Feb 25, 2015 · Class II · Noven Pharmaceuticals, Inc.
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Lots: Lot # 76476; Exp 07/16
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Estradiol: every company that makes it
- Form
- film, extended release, transdermal
- Strength
- 0.075 mg per 1 d
- Approval
- NDA NDA203752
- On the market since
- Dec 20, 2012
- Package NDCs
68968-6675-8- Official label
- DailyMed (National Library of Medicine), updated Jul 31, 2026
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