FDA Drug recall D-0336-2021
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc by Noven Pharmaceuticals, citing 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, patien….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0336-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-16 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
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
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.
Identifiers
| ndc | 68968-6625-8 |
|---|---|
| ndc | 68968-6637-8 |
| ndc | 68968-6650-8 |
| ndc | 68968-6675-8 |
| ndc | 68968-6610-8 |
| code_info | Lot #: 88584 Exp. 03/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0336-2021%22
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