FDAFDA · Food and drugs·Recall number D-1081-2023
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
Published August 9, 2023 · Recall initiated: June 23, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TYDEMY
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- USA nationwide.
- UPC
- 0368180904717
- Lot
- Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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