Acella Pharmaceuticals is recalling two lots of its thyroid medication after testing found they may not be strong enough, the Food and Drug Administration announced last week.
The company is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid, Thyroid Tablets “because testing found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine."
Levothyroxine is one of two active ingredients in the drugs used to treat hypothyroidism, or an underactive thyroid. The other active ingredient is liothyronine.
Symptoms of hypothyroidism can return in patients treated for an underactive thyroid who take a subpotent drug, the FDA warned. Symptoms can 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 agency said.
"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," according to the announcement. "In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia."
Acella has received four reports of "adverse events” for the medication.
The recalled products were distributed nationwide and packed in 100-count bottles:
- NP Thyroid 15, Thyroid Tablets, USP, ? grain (15 mg), NDC No. 42192-327-01, Lot No. M327E19-1, expiration date October 2020
- NP Thyroid 120, Thyroid Tablets, USP, 2 grain (120 mg), NDC No. 42192-328-01, Lot No. M328F19-3, expiration date November 2020.
According to the announcement, Acella has “received four reports of adverse events” for the medication.
Medications with “use by,” “discard after” or “expiration date” on or after December 2020 are not impacted by the recall.
The FDA said Acella is proactively notifying its wholesalers to discontinue distribution of the recalled products. Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider first for further guidance and/or a replacement prescription.
Consumers with questions about the recall can email Acella Pharmaceuticals at email@example.com or call 1-888-280-2044 Monday through Friday from 8:00 a.m. ET to 5 p.m. ET.
This is the second recall this month related to deficiencies in the active ingredients in drugs used to treat hypothyroidism. Earlier this month,?RLC Labs recalled?483 lots of Nature-Throid and WP Thyroid because tests revealed they "may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4)."