FDA Recall Estradiol

The most recent Recall Enforcement Report that covers this product was initiated on April 16th, 2021 and classified as a Class II recall due to 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 recall is currently terminated, and the associated recall number is recall number is D-0337-2021. It pertains to Estradiol identified by 68968-3410 as of 10-11-2024 .

Recall Number D-0337-2021

Event ID

87741 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-0337-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

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

Reason For Recall

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. What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

10872 cartons Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

04-28-2021

Recall Initiation Date

04-16-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Termination Date

10-11-2024 What is the Date Terminated?
The date that FDA terminated the recall.

Initial Firm Notification

Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

Noven Pharmaceuticals Inc

Code Info/dt>

Lot #: 88321 Exp. 02/2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

68968-3425-8; 68968-3437-8; 68968-3450-8; 68968-3475-8; 68968-3410-8

Status

Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.