FDA Drug recall D-1209-2018
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc by Noven Pharmaceuticals, citing defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1209-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-07 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Identifiers
| ndc | 68968-6625-8 |
|---|---|
| ndc | 68968-6637-8 |
| ndc | 68968-6650-8 |
| ndc | 68968-6675-8 |
| ndc | 68968-6610-8 |
| code_info | Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019 |
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-1209-2018%22
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