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GIF withdraws several batches of TIROSINT SOL due to a quality defect

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The Chief Pharmaceutical Inspector issued a decision to recall sixteen batches of the drug TIROSINT SOL from the market throughout the country. As indicated in the justification for the decision, the reason for the decision is the finding of a quality defect during the tests.

Based on the decision of the GIF, the following batches of TIROSINT SOL in various doses were withdrawn from the market in the country:

TIROSINT SOL (Levothyroxinum natricum), 13 mcg oral solution in a single-dose container lot number: 220751, expiry date: 31/01/2024 TIROSINT SOL (Levothyroxinum natricum), 25 mcg oral solution in a single-dose container lot number: 220420, expiry date: 31/10 .2023 lot number: 220966, expiry date: 31/03/2024 lot number: 221066, expiry date: 04/30/2024 TIROSINT SOL (Levothyroxinum natricum), 50 mcg oral solution in a single dose container lot number: 220965, expiry date: 31/03/2024 lot number: 221153, expiry date: 31/05/2024 TIROSINT SOL (Levothyroxinum natricum), 75 mcg, oral solution in single-dose container lot number: 221159, expiry date: 31/05/2024 TIROSINT SOL (Levothyroxinum natricum), 88 mcg, oral solution in single-dose container lot number: 220968, expiry date: 31/03/2024 TIROSINT SOL (Levothyroxinum natricum), 100 mcg oral solution in single-dose container lot number: 221062 , expiry date: 30/04/2024 TIROSINT SOL (Levothyroxinum natricum), 112 mcg, solution oral single-dose container lot number: 220970, expiry date: 31/03/2024 TIROSINT SOL (Levothyroxinum natricum), 137 mcg oral solution in single-dose container lot number: 221052, expiry date: 30/04/2024 TIROSINT SOL (Levothyroxinum natricum), 150 mcg , oral solution in a single-dose container lot number: 220857, expiry date: 28/02/2024 lot number: 221051, expiry date: 30/04/2024 TIROSINT SOL (Levothyroxinum natricum), 175 mcg, oral solution in a single-dose container lot number: 221070, expiry date : 30/04/2024 TIROSINT SOL (Levothyroxinum natricum), 200 mcg, oral solution in a single-dose container lot number: 220560, expiry date: 30/11/2023 lot number: 221151, expiry date: 05/31/2024

The responsible entity is IBSA Farmaceutici Italia SrL z Italian.

“The Main Pharmaceutical Inspectorate received information from a Qualified Person from IBSA Farmaceutici Italia SrL regarding the preventive recall of the indicated series of TIROSINT SOL medicinal products, manufactured with the use of an excipient – glycerol from a new supplier, due to the likelihood of obtaining results outside the specification in terms of the content of the active substance – levothyroxine sodium, therefore, the quality cannot be guaranteed” – stated in the justification to the decision.

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GIF stated that “due to the likelihood of a reduced content of the active substance in the product, a risk to the patient’s health cannot be excluded resulting from reduced drug efficacy.

The active substance of TIROSINT SOL is a synthetically produced thyroid hormone – levothyroxine sodium (T4), which has the same structure and effect as naturally occurring thyroid hormone. TIROSINT SOL is used, among other things, as thyroid hormone replacement therapy in case of deficiency caused by insufficient thyroid function. It is also taken to stop tumor (malignancy) growth in the thyroid gland, especially after surgery, and as thyroid hormone replacement therapy when there is a deficiency

Main photo source: Shutterstock



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