IBSA Pharma recalls TIROSINT levothyroxine oral solution (125 mcg/mL) with potential subpotent drug levels. This may not provide adequate thyroid hormone. Affected units have NDC 71858-0140-5 and lot 220855.
Subpotent Drug
IBSA Pharma is recalling TIROSINT levothyroxine oral solution because it may contain less active drug than labeled. This could lead to inadequate thyroid hormone levels if used as directed.
The product may contain less active levothyroxine than labeled, potentially leading to insufficient thyroid hormone levels. This could cause symptoms like fatigue, weight gain, or depression if not properly managed.
Prescription patients using TIROSINT levothyroxine oral solution with NDC 71858-0140-5 and lot number 220855. Those with thyroid hormone replacement therapy are most at risk.
Check for the product name 'TIROSINT - SOL (levothyroxine sodium) Oral Solution' with 125 microgram/mL concentration. Look for NDC 71858-0140-5 and lot number 220855 on the packaging.
Verify the product label for NDC 71858-0140-5 and lot number 220855.
The recall states it may contain less active drug than labeled, but the product is not unsafe to use. Patients should contact their doctor for guidance.
The recall does not specify a remedy, so contact your doctor or pharmacist for advice on whether to continue using the product.
Check the product label for NDC 71858-0140-5 and lot number 220855.
We’ve drafted a message you can send IBSA Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0333-2023 — IBSA Pharma IBSA Pharma Hello, I own a IBSA Pharma that is covered by recall D-0333-2023 from IBSA Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
