IBSA Pharma is recalling the hypothyroid medication because analyses showed lowered levels of levothyroxine in some lots.
IBSA Pharma is voluntarily recalling 27 lots of Tirosint-SOL (levothyroxine sodium) Oral Solution, which is used to treat patients with hypothyroidism, as well as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent thyroid cancer.
This recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.
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. IBSA Pharma has not received any reports of adverse events that have been determined to be related to this recall.
The recall doesn’t apply to Tirosint capsules.
Tirosint-SOL is a clear solution supplied in a 1 mL white, non-transparent, unit-dose ampule. The dosage strength is identified on the box and the pouch. Each ampule bears a colored label with the dosage strength and the product name. Lot and NDC numbers associated with the recall can be found here.
More than 12% of the U.S. population will develop a thyroid condition during their lifetime, and an estimated 20 million Americans have some form of thyroid disease, according to the American Thyroid Association.