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Class II · ModerateRecall completed

Tirosint

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 220415, Exp. 10/2023; 221052, Exp. 04/2024.
Where it was soldNationwide in the USA.
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

Subpotent Drug

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 byIBSA Pharma Inc.
Brand nameTIROSINT
Generic nameLEVOTHYROXINE SODIUM
Active ingredient(s)LEVOTHYROXINE SODIUM
Distributed by / forIBSA Pharma Inc., Parsippany, NJ 07054;
NDC71858-0145-5
Show the full FDA record
Full product labelTIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0145-5
Recalling firmIBSA PHARMA INC
DistributionNationwide in the USA.
QuantityN/A
Recall initiated2023-01-30
Report date2023-03-01
Recall completed2023-10-31
Recall numberD-0343-2023
ClassificationClass II
FDA statusTerminated
Origin on fileParsippany NJ 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.