D-0863-2018 Class II Terminated
FDA drug recall D-0863-2018 was initiated by Noven Pharmaceuticals, Inc. on May 4, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 70870 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 16, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- Jun 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70870 boxes
Product Description
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 81896, Exp. 03/19; 82264 Exp. 12/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0863-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026