October 29, 2020
A Class I recall has been issued for two lots of NP Thyroid tablets (levothyroxine [T4] and liothyronine [T3]) because of subpotency, according to the October 28, 2020, US Food and Drug Administration (FDA) Enforcement Report. Under the recall classification, use of the affected tablets could cause serious adverse health consequences or death.
The tablets may have as low as 87% of the labeled amount of levothyroxine (T4), recalling firm Acella Pharmaceuticals stated in a September 17, 2020, announcement. The company had received four reports of adverse events possibly related to the recall at the time of the announcement.
“Patients being treated for hypothyroidism (underactive thyroid) who receive subpotent 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,” the company announcement stated. “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.”
The recall includes the following products, distributed throughout the United States:
- NP Thyroid tablets, ¼ grain (15 mg), 100-count bottles (NDC 42192-327-01), from lot M327E19-1 (Exp. 10/20); and
- NP Thyroid tablets, 2 grain (120 mg), 100-count bottles (NDC 42192-328-01), from lot M328F19-3 (Exp. 11/20).
Acella Pharmaceuticals voluntarily initiated the recall September 17, 2020. On October 19, 2020, the FDA designated the recall Class I.
Composed of levothyroxine and liothyronine, NP Thyroid is available with a prescription to treat hypothyroidism.