The last Recall Enforcement Report for Tydemy with NDC 68180-904 was initiated on 06-23-2023 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 The latest recall number for this product is D-1081-2023 and the recall is currently ongoing .
Recall Number D-1081-2023
| Field Name |
Field Value |
| 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. |
| 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 |
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 |
Ongoing |
|
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.