Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and...
FDA Recall #D-0264-2022 — Class III — November 19, 2021
Product Description
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
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4113 cartons
Distribution
nationwide within the United States
Code Information
Lot #: L000784 and L000785, Exp. Date May 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated