The Spanish Agency for Medicines and Health Products (Aemps) has announced the withdrawal from Solsint, a medicine manufactured by Ibsa that is used for the thyroid, having detected a “out of specification result in the content of the active ingredient levothyroxine & rdquor; in some lots.
However, Aemps reports in its alert that said defect “It does not pose a serious or vital risk to the patient& rdquor;as well as that it has proceeded to “withdraw from the market all the units distributed from the affected batches and return them to the laboratory through the usual channels& rdquor ;.
Solsint replaces thyroid hormone deficiency in those people who have the underactive thyroid gland
The formats in which the withdrawal of the product has been applied are those of between 25 and 175 micrograms. And these are the affected batches:
SOLSINT 25 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 single-dose containers (NR: 85617, CN: 729906) Lot: 220657, expiration date 12/31/2023
SOLSINT 50 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 single-dose containers (NR: 85618, CN: 729908) Lot: 220752, expiration date 01/31/2024
SOLSINT 100 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 single-dose containers (NR: 85609, CN: 729889) Lot: 220658, expiration date 12/31/2023
SOLSINT 125 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 single-dose containers (NR: 85611, CN: 729893) Lot: 220753, expiration date 01/31/2024
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SOLSINT 137 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 single-dose containers (NR: 85612, CN: 729895) Lot: 220755, expiration date 01/31/2024
SOLSINT 175 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85615, CN: 729901) Lot: 220662, expiration date 12/31/2023