D-1209-2018 Class II Terminated
FDA drug recall D-1209-2018 was initiated by Noven Pharmaceuticals, Inc. on September 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 September 9, 2020). Affected quantity: 26217 boxes of 8 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2018
- Initiation Date
- September 7, 2018
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26217 boxes of 8 patches
Product Description
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 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
Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019