Drug recall D-0264-2022

Class III Terminated reported Dec 8, 2021

Product

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.

Reason for recall

Subpotent Drug

Lots and codes

Lot #: L000784 and L000785, Exp. Date May 2022

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
4113 cartons
Distribution
nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
November 19, 2021
Terminated
November 15, 2022

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