Tydemy Kit
FDA Recall NDC 68180-904
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 Tydemy (NDC 68180-904). A significant event, classified as Class I, was initiated on Jun 23, 2023 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test"
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
June 2023 Class I Recall: Failed Stability Specification and Failed Impurities/Degradation Specifications
Recall Number
Class I Terminated
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Jun 23, 2023
Aug 09, 2023
4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
Recall Profile & Regulatory Data
Event ID
92588
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Jan 28, 2025
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
Batch or Lot Expiration Information
Lot# : L200183, Exp 1/2024; L201560, Exp 9/2024
Affected Packages Involved in this Recall
68180-904-73Product
68180-905-74Product
68180-910-74Product
68180-904-71Product
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.
