2-02-2023 10:49am

Select Lots of TIROSINT-SOL (levothyroxine sodium) Oral Solution by IBSA Pharma: Recall

Anita Johnson-Brown Editor

Patients, Health Professionals, Pharmacy, and Endocrinology healthcare workers, FDA MedWatch announced the recall of IBSA Pharma's 27 lots of TIROSINT-SOL (levothyroxine sodium) Oral Solution because these lots may be sub-potent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.

This recall does not apply to TIROSINT (levothyroxine sodium) capsules.

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub-potent TIROSINT-SOL, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. Over- or under-treatment with TIROSINT-SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism.

To date, IBSA Pharma has not received any reports of adverse events that have been determined to be related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: TIROSINT - SOL is indicated for:

Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

THE RECOMMENDATIONS ARE SPECIFIED BELOW:

Any patients including those who might be pregnant, newborn infants, or elderly patients, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Patients who are currently taking TIROSINT - SOL should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
Patients and healthcare providers with questions regarding this recall can contact the company.
IBSA Pharma is notifying its wholesalers, retailers, and healthcare providers to discontinue distribution of the product being recalled and is arranging for the return of all recalled products.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, and complete and return it to the address on the form, or submit it by fax to 1-800-FDA-0178.