Drug recall D-0724-2021
Product
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.
Lots and codes
Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Recall details
- Recalling firm
- Noven Pharmaceuticals Inc, Miami, FL
- Quantity
- 223,382 boxes
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 30, 2021
Related products
- CombiPatch (estradiol/norethindrone acetate transdermal system) – drug information
- NDC 68968-0514 CombiPatch (estradiol/norethindrone acetate transdermal system) · Estradiol .05 mg/d; Norethindrone Acetate .14 mg/d · Noven Therapeutics, LLC
- NDC 68968-0525 CombiPatch (estradiol/norethindrone acetate transdermal system) · Estradiol .05 mg/d; Norethindrone Acetate .25 mg/d · Noven Therapeutics, LLC