Drug product
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA
D-1081-2023
Product summary
- Event
- Event 92588
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
- Official record key
drug-enforcement:D-1081-2023
Official wording
Reason: Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Code information: Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
out of specification