D-0724-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 30, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 223,382 boxes
Product Description
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
Reason for Recall
Failed Stability Specifications; out of specification for shear.
Distribution Pattern
Nationwide.
Code Information
Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022