D-0264-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 8, 2021
- Initiation Date
- November 19, 2021
- Termination Date
- November 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4113 cartons
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
Distribution Pattern
nationwide within the United States
Code Information
Lot #: L000784 and L000785, Exp. Date May 2022