The warning arises from a “possible result out of specifications in the content of the active substance levothyroxine”
The Spanish Agency for Medicines and Health Products (Aemps) has published this Wednesday a health alert for a drug that is used, among other things, to treat hyper and hypothyroidism.
Is about alone in half of the formats that are available for sale in Spain. The agency, dependent on the Ministry of Health, has announced that precautionary measures have already been taken and that have been withdrawn from the market all the distributed units of the affected batches and they have been returned to the laboratory through the usual channels.
As detailed by Aemps, the alert is due to a “possible result out of specifications in the content of the active ingredient levothyroxine.” It is a “quality defect that not life threatening for the patient,” they say.
SOLSINT 112 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85610, CN: 729891)
Batch: 220852, expiration date 02/29/2024
SOLSINT 13 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85613, CN: 729897)
Batch: 220751, expiration date 01/31/2024
SOLSINT 150 MICROGRAMS ORAL SOLUTION IN UNITED PACKAGES, 30 single-dose containers (NR: 85614, CN: 729899)
Batch: 220857, expiration date 02/28/2024
SOLSINT 200 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85616, CN: 729903)
Batch: 220860, expiration date 02/28/2024
SOLSINT 75 MICROGRAMS, ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85619, CN: 729910)
Batch: 220853, expiration date 02/28/2024
SOLSINT 88 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85620, CN: 729912)
Batch: 220854, expiration date 02/28/2024
What is Solsint used for?
According to the package leaflet, Solsint is used as replacement therapy for thyroid hormone deficiency in cases of an underactive thyroid gland (hypothyroidism) and as concomitant therapy during treatment of excess thyroid hormones (hyperthyroidism).
In addition, it is used for the prevention of goiter recurrence after surgery in patients with normal thyroid function, the treatment of benign goiter in patients with normal thyroid function, and the treatment of malignant thyroid tumors, especially after surgery to suppress the growth of a goiter. new tumor, and as a supplement to the lack of thyroid hormones.
Finally, it also has a diagnostic use for the thyroid suppression test.
report a bug