Acella Pharmaceuticals is recalling 38 lots of its thyroid drug after routine testing conducted by the drugmaker found the drug to be subpotent.
The recalled lots contain less than 90% of the labeled amount of liothyronine and/or levothyroxine, the ingredients that make up the drug. The drug is designed to treat hypothyroidism, or underactive thyroid.
Acella has received 43 reports of serious adverse events that may be linked to the recall.
Patients taking the drug to treat hypothyroidism who receive the subpotent drug could 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, the FDA said.
The FDA said there's a reasonable risk of serious injury in newborn infants or pregnant women with hypothroidism, including early miscarriage, fetal hyperthyroidism and impairments to fetal neural and skeletal development.
In elderly patients and those with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism could occur, including cardiac pain, palpitations or arrhythmia.
Read the FDA's full news release here.