Drug 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.
D-0264-2022
Product summary
- Event
- Event 89085
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4113 cartons
- Official record key
drug-enforcement:D-0264-2022
Official wording
Reason: Subpotent Drug
Code information: Lot #: L000784 and L000785, Exp. Date May 2022
Distribution pattern: nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent