The U.S. Food and Drug Administration (FDA) on Thursday announced the recall of a thyroid medication after it was found that lots of the drug may be “subpotent.”
IBSA Pharma Inc. confirmed it is recalling Tirosint-SOL, or levothyroxine sodium, a medication used to treat an underactive thyroid gland. It said that the “voluntary recall has been initiated because these lots may be subpotent,” stated the announcement, published on the FDA’s website.
“The company’s analyses show a slight decrease below 95.0 percent of its labeled amount in levothyroxine sodium (T4) for some lots,” according to the recall notice. The recall doesn’t apply to Tirosint capsules.
People who take the recalled, subpotent drug could “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,” the notice said.
Other side-effects, it said, may include “negative effects” on bone metabolism, reproductive function, cardiovascular function, growth and development, gastrointestinal function, cognitive function, emotional state, and glucose and lipid metabolism, the company said.
Read more: FDA Issues Alert, Announces Recall of Common Thyroid Medication
