FDA Recall Tydemy

The most recent Recall Enforcement Report that covers this product was initiated on June 23rd, 2023 and classified as a Class I recall due to failed stability specification and failed impurities/degradation specifications: out of specification for inactive content ascorbic acid and mthfrc-7impurity test This recall is currently terminated, and the associated recall number is recall number is D-1081-2023. It pertains to Tydemy identified by 68180-904 as of 01-28-2025 .

Recall Number D-1081-2023

Event ID

92588 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-1081-2023 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. 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

USA nationwide. 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

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA

Reason For Recall

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch 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

08-09-2023

Recall Initiation Date

06-23-2023 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Termination Date

01-28-2025 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

Lupin Pharmaceuticals Inc.

Code Info/dt>

Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024 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

68180-904-73; 68180-905-74; 68180-910-74; 68180-904-71

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.