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
Reported: August 25, 2021 Initiated: July 30, 2021 #D-0724-2021
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.
Details
- Recalling Firm
- Noven Pharmaceuticals Inc
- Units Affected
- 223,382 boxes
- Distribution
- Nationwide.
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Noven Pharmaceuticals Inc. Units affected: 223,382 boxes.
Why was this product recalled? ▼
Failed Stability Specifications; out of specification for shear.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0724-2021.
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