Estradiol Film, Extended Release
FDA Recall NDC 68968-3450
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Estradiol (NDC 68968-3450). A significant event, classified as Class II, was initiated on Apr 16, 2021 by Noven Therapeutics, Llc. The reported reason for this action was: "Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Apr 16, 2021
Apr 28, 2021
10872 cartons
Recall Profile & Regulatory Data
Event ID
87741
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Noven Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 11, 2024
Product Description
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8
Batch or Lot Expiration Information
Lot# : 88321 Exp. 02/2022
Affected Packages Involved in this Recall
68968-3425-8Product
68968-3437-8Product
68968-3450-8Product
68968-3475-8Product
68968-3410-8Product
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.
