WASHINGTON, D.C. – Two different doses of a thyroid medication are being recalled because they're not potent enough.
The Food and Drug Administration announced Thursday that Acella Pharmaceuticals is voluntarily recalling one lot of 15-milligram and one lot of 120-milligram NP Thyroid®, Thyroid Tablets.
The products may have as low as 87% of the labeled amount of levothyroxine, which is used to treat hypothyroidism (an underactive thyroid), according to the FDA.
The company’s risk statement says patients being treated for hypothyroidism who receive sub potent NP Thyroid may experience symptoms of hypothyroidism, including 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,” wrote Acella. “In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.”
So far, Acella says it has received four reports of "adverse events" for these lot numbers, possibly related to the recall.
The products subject to recall are packed in 100-count bottles. Their lot numbers are M327E19-1 and M328F19-3. And their expiration dates are Oct. 2020 and November 2020.
The products were distributed nationwide to Acella’s direct accounts, including wholesalers, pharmacies, and health care offices.
“Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the two above referenced lots being recalled and is arranging for return of all recalled products,” wrote the company.
Anyone who is currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their health care provider for further guidance and/or a replacement prescription, according to Acella.
Anyone with questions about the recall can email Acella at recall@acellapharma.com or contact a representative at 1-888-280-2044.