FDA Drug recall D-0862-2018
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…
- FDA Drug
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of 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… by Noven Pharmaceuticals, citing 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 exp….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0862-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-04 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| ndc | 68968-6625-8 |
|---|---|
| ndc | 68968-6637-8 |
| ndc | 68968-6650-8 |
| ndc | 68968-6675-8 |
| ndc | 68968-6610-8 |
| ndc | 68968-6610-1 |
| code_info | Lot #: 81391, 81638 Exp. 10/18 |
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-0862-2018%22
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