Combipatch (estradiol/norethindrone Acetate Transdermal System) Patch, Extended Release
FDA Recall NDC 68968-0525
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Combipatch (estradiol/norethindrone Acetate Transdermal System) (NDC 68968-0525). A significant event, classified as Class II, was initiated on Jul 30, 2021 by Noven Therapeutics, Llc. The reported reason for this action was: "Failed Stability Specifications; out of specification for shear."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
July 2021 Class II Recall: Failed Stability Specifications; out of specification for shear.
Recall Number
Class II Ongoing
Failed Stability Specifications; out of specification for shear.
Jul 30, 2021
Aug 25, 2021
223,382 boxes
Recall Profile & Regulatory Data
Event ID
88342
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
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
Batch or Lot Expiration Information
Lot# Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Affected Packages Involved in this Recall
68968-0514-8Product
68968-0525-8Product
68968-0514-2Product
July 2021 Class II Recall: Failed Stability Specifications; out of specification for shear.
Recall Number
Class II Ongoing
Failed Stability Specifications; out of specification for shear.
Jul 30, 2021
Aug 25, 2021
70,638 boxes
Recall Profile & Regulatory Data
Event ID
88342
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Product Description
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
Batch or Lot Expiration Information
Lot# Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
Affected Packages Involved in this Recall
68968-0514-8Product
68968-0525-8Product
68968-0525-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
