Multi event Drug Recall Enforcement Report Class II voluntary initiated by Noven Pharmaceuticals, Inc., originally initiated on 09-07-2018 for the product Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8 The product was recalled due to defective delivery system: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1207-2018 | 09-07-2018 | 10-03-2018 | Class II | 213714 boxes of 8 patches and 15927 boxes of 2 patches | Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
| D-1210-2018 | 09-07-2018 | 10-03-2018 | Class II | 74908 boxes of 8 patches | Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
| D-1209-2018 | 09-07-2018 | 10-03-2018 | Class II | 26217 boxes of 8 patches | 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 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
| D-1208-2018 | 09-07-2018 | 10-03-2018 | Class II | 149631 boxes of 8 patches and 15809 boxes of 2 patches | 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 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 68968-6610 | Minivelle | Estradiol | Film, Extended Release | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
| 68968-6625 | Minivelle | Estradiol | Film, Extended Release | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
| 68968-6637 | Minivelle | Estradiol | Film, Extended Release | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
| 68968-6650 | Minivelle | Estradiol | Film, Extended Release | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
| 68968-6675 | Minivelle | Estradiol | Film, Extended Release | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
