April 30, 2021
Acella Pharmaceuticals has voluntarily recalled more than 30 lots of 15mg, 30mg, 60mg, 90mg, and 120mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)]. The affected lots were found to be subpotent, containing less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4), during routine testing.
NP Thyroid is used to treat hypothyroidism (underactive thyroid). Patients who take subpotent NP Thyroid to treat hypothyroidism may experience signs and symptoms of underactive thyroid such as 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. According to the recall announcement, there is a reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism who take subpotent NP Thyroid. These risks include early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. For elderly patients and patients who have underlying cardiac disease, use of subpotent NP Thyroid could lead to toxic cardiac manifestations of hyperthyroidism such as cardiac pain, palpitations, or cardiac arrhythmia.
As of April 29, 2021, Acella had received 43 reports of serious adverse events potentially related to the recalled product.
Patients currently taking NP Thyroid from the affected lots should not discontinue use without contacting their healthcare provider for guidance. Consumer questions about the recall can be directed to Acella at 1-888-424-4341 or email@example.com. If patients experience any problems that may be related to use of the recalled product, they should contact their healthcare provider. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
A full copy of the recall announcement, including details of the recalled lots of NP Thyroid, can be found
on the FDA’s website.
There is no member impact through Benecard Central Fill.