Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg a...
FDA Recall #D-1081-2023 — Class I — June 23, 2023
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
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
Distribution
USA nationwide.
Code Information
Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated