Noven Pharmaceuticals Inc: Drug Recall
Recall #D-0725-2021 · 07/30/2021
Class II: Risk
Recall Details
- Recall Number
- D-0725-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Noven Pharmaceuticals Inc
- Status
- Ongoing
- Date Initiated
- 07/30/2021
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,638 boxes
Reason for Recall
Failed Stability Specifications; out of specification for shear.
Product Description
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
Distribution Pattern
Nationwide.
Other Recalls by Noven Pharmaceuticals Inc
- Class II: Risk 10/31/2024
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.