{"id":170445,"date":"2023-02-02T11:37:07","date_gmt":"2023-02-02T11:37:07","guid":{"rendered":"https:\/\/precoinnews.com\/?p=170445"},"modified":"2023-02-02T11:37:07","modified_gmt":"2023-02-02T11:37:07","slug":"ibsa-pharma-recalls-tirosint-sol-oral-solution","status":"publish","type":"post","link":"https:\/\/precoinnews.com\/business\/ibsa-pharma-recalls-tirosint-sol-oral-solution\/","title":{"rendered":"IBSA Pharma Recalls TIROSINT-SOL Oral Solution"},"content":{"rendered":"
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.<\/p>\n
Meanwhile, the recall does not apply to TIROSINT (levothyroxine sodium) capsules.<\/p>\n
TIROSINT-SOL is indicated for Hypothyroidism and Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
However, IBSA Pharma has not received any reports of adverse events related to the recalled drug to date.<\/p>\n
TIROSINT-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. <\/p>\n
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.<\/p>\n
For More Such Health News, visit rttnews.com <\/p>\n