D-1208-2018 Class II Terminated
FDA drug recall D-1208-2018 was initiated by Noven Pharmaceuticals, Inc. on Sep 7, 2018 and is designated Class II. Reason for recall: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. The recall status is terminated (terminated Sep 9, 2020). Affected quantity: 149631 boxes of 8 patches and 15809 boxes of 2 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 3, 2018
- Initiation Date
- Sep 7, 2018
- Termination Date
- Sep 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149631 boxes of 8 patches and 15809 boxes of 2 patches
Product Description
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
Reason for Recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Distribution Pattern
Nationwide
Code Information
a) 82292 Exp. 02/2019; b) 82139 Exp. 10/2018; 82292 Exp. 02/2019; and 82598 Exp. 04/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1208-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026