Acella Pharma Recalls Thyroid Drugs For Sub Potency
Acella Pharmaceuticals, LLC recalled certain lots of hypothyroidism medication NP Thyroid in the form of tablets due to sub potency, the U.S. Food and Drug Administration said in a statement.
The company is recalling 35 commercial lots and three sample lots, including four lots of 15-mg, three lots of 30-mg, 11 lots of 60-mg, seven lots of 90-mg and ten lots of 120-mg of NP Thyroid that are packaged in 100 count bottles, with expiration dates between April 2021 and March 2022.
The three sample lots included one lot each of 15-mg, 30-mg and 120-mg strength of NP Thyroid that are packaged in 7 count sample bottles, with expiration dates between August 2021 and March 2022.
NP Thyroid is composed of levothyroxine and liothyronine and used to treat hypothyroidism or an underactive thyroid. According to the company, the product may have less than 90 percent of the labeled amount of Liothyronine (T4) and/or levothyroxine (T4).
These lots were distributed across the U.S. to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices.
Acella noted that if patients are treated for hypothyroidism with these sub potent NP Thyroid tablets, they may experience signs and symptoms of hyperthyroidism, including swelling of the thyroid gland or weight gain, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate and depression.
Newborn infants or pregnant women who take sub potent NP Thyroid also may experience early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development.
Acella said it has received 43 reports of serious adverse events until date related to the recalled products.
“Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription,” the company added.
In September 2020, Acella Pharmaceuticals recalled two lots of NP Thyroid in the form of tablets due to sub potency. Earlier in May 2020, it had also recalled 13 lots of NP Thyroid in the form of tablets due to super potency.
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