FDA Drug recall D-0725-2021
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-052…
- FDA Drug
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-052… by Noven Pharmaceuticals, citing failed Stability Specifications; out of specification for shear.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0725-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-30 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Noven Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Failed Stability Specifications; out of specification for shear.
Identifiers
| ndc | 68968-0514-8 |
|---|---|
| ndc | 68968-0525-8 |
| ndc | 68968-0525-2 |
| code_info | Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0725-2021%22
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