Recall D-0264-2022
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.
Recall D-0264-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0264-2022 |
Event ID | 89085 |
Distribution | nationwide within the United States |
Quantity | 4113 cartons |
Recall Reason | Subpotent Drug |
Drug Classification | Class III |
Drug Code Info | 20211208 |
Recall Initiation Date | 20211119 |
Report Date | 20211208 |
Classification Date | 20211201 |
Address | Harborplace Tower111 S Calvert St Fl 21st Baltimore, MD 21202-6174 United States |
Recalling Firm | Lupin Pharmaceuticals Inc. |
Initial Notification | Letter |
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