Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2
Summary
The FDA issued a Class II for Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per by Noven Pharmaceuticals Inc. Reason: Failed Stability Specifications; out of specification for shear..
Details
Source
Drug Recall
External ID
D-0724-2021
Action Date
2021-08-25
Status
Ongoing
Category
drug
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
Lot/Code Info: Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Quantity Affected: 223,382 boxes
Reason for Recall
Failed Stability Specifications; out of specification for shear.
Distribution
Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-30
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Noven Pharmaceuticals Inc has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Noven Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Noven Pharmaceuticals Inc have FDA actions?
Noven Pharmaceuticals Inc has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0724-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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