Recalls / Class I

Class ID-1081-2023

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

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

Brand name: Tydemy
Generic name: Drospirenone, Ethinyl Estradiol And Levomefolate Calcium And Levomefolate Calcium
NDC: 68180-904
FDA application: ANDA205948
Affected lot / code info: Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024

Why it was recalled

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Recalling firm

Firm: Lupin Pharmaceuticals Inc.
Manufacturer: Lupin Pharmaceuticals, Inc.
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174

Distribution

Quantity: 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
Distribution pattern: USA nationwide.

Timeline

Recall initiated: 2023-06-23
FDA classified: 2023-08-04
Posted by FDA: 2023-08-09
Terminated: 2025-01-28
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1081-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.