Drug 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
D-0725-2021
Product summary
- Event
- Event 88342
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70,638 boxes
- Official record key
drug-enforcement:D-0725-2021
Official wording
Reason: Failed Stability Specifications; out of specification for shear.
Code information: Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
out of specification