June 12, 2020
A Class I recall has been issued for 13 lots of NP Thyroid (thyroid tablets) because of superpotency, according to the June 10, 2020, US Food and Drug Administration (FDA) Enforcement Report. The classification signals use of the affected tablets could cause serious adverse health consequences or death.
The tablets may have up to 115% of the labeled amount of liothyronine (T3), recalling firm Acella Pharmaceuticals stated in a May 22, 2020, announcement. The company had received two reports of adverse events at the time of the announcement.
“Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances,” the company stated. “Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development.”
The recall includes the following products, distributed throughout the United States and in Puerto Rico:
- NP Thyroid 30 mg, 100-count bottles (NDC 42192-329-01) from lots M329H18-1 (Exp. 7/20), M329J18-1, M329J18-2, and M329J18-3 (Exp. 8/20), M329M18-2 (Exp. 11/20), and M329A19-1 (Exp. 12/20);
- NP Thyroid 60 mg, 100-count bottles (NDC 42192-330-01) from lots M330J18-2A and M330J18-3 (Exp. 8/20); and
- NP Thyroid 90 mg, 100-count bottles (NDC 42192-331-01) from lots M331G18-1 (Exp. 6/20), M331J18-1 and M331J18-2 (Exp. 8/20), and M331M18-1 and M331M18-2 (Exp. 11/20).
Acella Pharmaceuticals voluntarily initiated the recall on May 22, 2020. The FDA designated the recall Class I on June 8, 2020.
Composed of levothyroxine and liothyronine, NP Thyroid is available with a prescription to treat hypothyroidism.