Recalls / Class II
Class IID-0725-2021
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
- Brand name
- Combipatch (estradiol/norethindrone Acetate Transdermal System)
- Generic name
- Estradiol/norethindrone Acetate Transdermal System
- Active ingredients
- Estradiol, Norethindrone Acetate
- Route
- Transdermal
- NDCs
- 68968-0514, 68968-0525
- FDA application
- NDA020870
- Affected lot / code info
- Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
Why it was recalled
Failed Stability Specifications; out of specification for shear.
Recalling firm
- Firm
- Noven Pharmaceuticals Inc
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- 70,638 boxes
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2021-07-30
- FDA classified
- 2021-08-13
- Posted by FDA
- 2021-08-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0725-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.