WASHINGTON (NewsNation Now) — Two types of thyroid medications are being voluntarily recalled by the manufacturer, according to the Food and Drug Administration. The NP Thyroid tablets made by Acella Pharmaceuticals, LLC have possibly led to at least four reports of adverse effects.
According to the company statement, several problems, including heart issues, could be associated with the recalled drugs.
Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may 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. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.Acella Pharmaceuticals, LLC in fda statement
NP Thyroid 15 and NP Thyroid120 are being recalled because testing found the lots to be sub-potent.
“The product may have as low as 87% of the labeled amount of levothyroxine,” according to the FDA announcement.
The prescription drugs were sent to pharmacies across the country.
“Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription,” according to the FDA announcement.
|Product||NDC||Lot #||Exp. Date|
|NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg)||42192-327-01||M327E19-1||October 2020|
|NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg)||42192-328-01||M328F19-3||November 2020|
Patients are encouraged to contact the company with questions and report adverse effects to the FDA.