Multi event Drug Recall Enforcement Report Class II voluntary initiated by Noven Pharmaceuticals Inc, originally initiated on 07-30-2021 for the product Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 The product was recalled due to failed stability specifications; out of specification for shear.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0724-2021 | 07-30-2021 | 08-25-2021 | Class II | 223,382 boxes | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 | Failed Stability Specifications; out of specification for shear. | Ongoing |
| D-0725-2021 | 07-30-2021 | 08-25-2021 | Class II | 70,638 boxes | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186 | Failed Stability Specifications; out of specification for shear. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 68968-0514 | Combipatch (estradiol/norethindrone Acetate Transdermal System) | Estradiol/norethindrone Acetate Transdermal System | Patch, Extended Release | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
| 68968-0525 | Combipatch (estradiol/norethindrone Acetate Transdermal System) | Estradiol/norethindrone Acetate Transdermal System | Patch, Extended Release | Transdermal | Noven Therapeutics, Llc | Human Prescription Drug |
