FDA Recall D-1081-2023
Lupin Pharmaceuticals Inc. · Baltimore, MD
Class I — life-threatening Terminated 585 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Recall record
- Recall number
D-1081-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide.
- Recall initiated
- 2023-06-23
- Classified by FDA Center
- 2023-08-04
- FDA published
- 2023-08-09
- Terminated
- 2025-01-28
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Firm location
- Baltimore, MD
Drug identification
- Brand name(s)
- TYDEMY
- Generic name(s)
- DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM
- Manufacturer(s)
- Lupin Pharmaceuticals, Inc.
- NDC(s)
68180-904