The Spanish Agency for Medicines and Health Products (AEMPS) has ordered the withdrawal from the market of six batches of Solsint (levothyroxine sodium), from the IBSA laboratory, due to a quality defect that "does not pose a vital risk to the patient".
As detailed in a statement by the AEMPS, under the Ministry of Health, in these six batches has been detected a "possible result out of specifications in the content of the active ingredient levothyroxine sodium".
Solsint is used as replacement therapy for thyroid hormone deficiency in cases of underactive thyroid gland (hypothyroidism) and as concomitant therapy during treatment of excess thyroid hormones (hyperthyroidism).
It is also indicated for the prevention of goiter recurrence after surgery in patients with normal thyroid function; treatment of benign goiter in patients with normal thyroid function; treatment of malignant thyroid tumors, especially after surgery to suppress the growth of a new tumor, and as a supplement to the lack of thyroid hormones; and as a diagnostic use for thyroid suppression testing.
Specifically, the affected batches are Solsint 112 micrograms oral solution in unit dose container, batch 220852, expiration date 29/02/2024; Solsint 13 micrograms oral solution in unit dose pack, batch 220751, expiry date 31/01/2024; Solsint 150 micrograms oral solution in unit dose pack; lot 220857, expiry date 28/02/2024; Solsint 200 micrograms oral solution in unit dose pack, lot 220860, expiry date 28/02/2024; Solsint 75 micrograms oral solution in unit dose pack, batch 220853, expiry date 28/02/2024; and Solsint 88 micrograms oral solution in unit dose pack, batch 220854, expiry date 28/02/2024.
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