FDA Recall Minivelle
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on April 16th, 2021 and classified as a Class II recall due to 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 recall is currently terminated, and the associated recall number is recall number is D-0336-2021. It pertains to Minivelle identified by 68968-6637 as of 10-11-2024 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0336-2021 | 04-16-2021 | 04-28-2021 | 12060 cartons | 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 | 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. | Terminated |
| D-1207-2018 | 09-07-2018 | 10-03-2018 | 213714 boxes of 8 patches and 15927 boxes of 2 patches | 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 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
| D-1208-2018 | 09-07-2018 | 10-03-2018 | 149631 boxes of 8 patches and 15809 boxes of 2 patches | 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 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
| D-1210-2018 | 09-07-2018 | 10-03-2018 | 74908 boxes of 8 patches | 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 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
| D-1209-2018 | 09-07-2018 | 10-03-2018 | 26217 boxes of 8 patches | 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 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
| D-0863-2018 | 05-04-2018 | 05-16-2018 | 70870 boxes | 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. | 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. | Terminated |
| D-0862-2018 | 05-04-2018 | 05-16-2018 | 61960 boxes | 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. | 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. | Terminated |
| D-0923-2017 | 04-27-2017 | 07-05-2017 | 14434 cartons | 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 | Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. | Terminated |
| D-0485-2015 | 02-25-2015 | 04-22-2015 | 720 transdermal patches | 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 | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
