IBSA Pharma Inc. is recalling 27 lots of TIROSINT-SOL (levothyroxine sodium) Oral Solution to the consumer level due to subpotency, the U.S. Food and Drug Administration said.
Meanwhile, the recall does not apply to TIROSINT (levothyroxine sodium) capsules.
TIROSINT-SOL is indicated for Hypothyroidism and Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression.
It is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism, as well as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well differentiated thyroid cancer.
The 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.
The agency noted that 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.
However, IBSA Pharma has not received any reports of adverse events related to the recalled drug to date.
TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule.
Patients who are currently taking TIROSINT-SOL are asked not to discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.
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