RecallDepth
Class I Terminated

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

This recall has been terminated (originally issued August 9, 2023).

Company
Lupin Pharmaceuticals Inc.
Recall Initiated
June 23, 2023
Posted
August 9, 2023
Recall Number
D-1081-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
Firm Location
Baltimore, MD, United States
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

USA nationwide.

Lot / Code Info

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

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