These are six batches of Solsint (sodium levothyroxine)
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 laboratory CLAIMdue to a quality defect that “does not pose a vital risk to the patient”.
As detailed in a statement by the AEMPS, dependent on the Ministry of Health, In these six lots, a “possible result out of specifications in the content of the active ingredient levothyroxine sodium” has been detected.
Solsint is used as a replacement treatment 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 single-dose container, batch 220852, expiration date 02/29/2024; Solsint 13 micrograms oral solution in single-dose container, lot 220751, expiration date 01/31/2024; Solsint 150 micrograms oral solution in unit dose container; lot 220857, expiration date 02/28/2024; Solsint 200 micrograms oral solution in single-dose container, lot 220860, expiration date 02/28/2024; Solsint 75 micrograms oral solution in single-dose container, lot 220853, expiration date 02/28/2024; and Solsint 88 micrograms oral solution in single-dose container, lot 220854, expiration date 02/28/2024.
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