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Class I · Most seriousRecall completed

Tydemy

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: L200183, Exp 1/2024; L201560, Exp 9/2024
Where it was soldUSA nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Pithampur (M.P.), INDIA foreign manufacturer
Brand nameTYDEMY
Generic nameDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202
NDC68180-904-71
Show the full FDA record
Full product labelTydemy (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
Recalling firmLupin Pharmaceuticals Inc.
DistributionUSA nationwide.
Quantity4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch
Recall initiated2023-06-23
Report date2023-08-09
Recall completed2025-01-28
Recall numberD-1081-2023
ClassificationClass I
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.