FDA Drug recall D-0923-2017
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, F…
- FDA Drug
- Class III
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class III recall of Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, F… by Noven Pharmaceuticals, citing defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0923-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-04-27 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Identifiers
| ndc | 68968-6625-8 |
|---|---|
| ndc | 68968-6637-8 |
| ndc | 68968-6650-8 |
| ndc | 68968-6675-8 |
| ndc | 68968-6610-8 |
| code_info | Lot #:: 78618, Exp. 05/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0923-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.