WASHINGTON, D.C. — Acella Pharmaceuticals, LLC, maker of NP Thyroid Tablets, USP, announced a voluntary recall of the medication because of extremely high potency rates with the medication. The U.S. Food and Drug Administration (FDA) published the notice of a voluntary recall on behalf of Acella Pharmaceuticals. The recall by Acella is for thirteen lots of NP Thyroid ® in doses of 30-mg, 60-mg, as well as 90-mg. All of the recalled medicine is sold in 100-dose bottles. The recall is noted by Acella and the FDA to be “to the consumer level,” which means that patients suffering from hypothyroidism might have the recalled medication at home. Consequently, all patients who take the drug must consult their physician about the recall and how they should replace the recalled medication.
Acella Pharmaceuticals said that its recalled NP Thyroid ® tablets might contain as much as 115% of the active ingredient Liothyronine (T3). Acella, in the statement published by the FDA, acknowledged that patients suffering from hypothyroidism, which is an underactive thyroid gland, would suffer from an overactive thyroid gland after taking the super-potent medication. Symptoms of hyperthyroidism include heat intolerance, losing weight, fatigue, high blood pressure, rapid heart rate, erratic heart rhythms, along with muscle weakness, and fatigue. Additionally, a pregnant woman who took the now recalled NP Thyroid ® could suffer a miscarriage or experience impairment in the fetus’s development.
Acella said that the company received two reports of events it described as “adverse.” The company did not disclose the nature of the events or the severity of the injury the patients suffered. Acella counseled patients to speak with their healthcare provider before discontinuing the use of the medicine. A physician could prescribe a substitute medication if necessary.
Acella reported that it distributed the super-potent pills across the United States. The company arranged the return of undistributed products from their distribution servicers.
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