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By RTTNews Staff Writer | Published: 9/18/2020 8:53 AM ET
Acella Pharmaceuticals, LLC recalled certain lots of hypothyroidism medication NP Thyroid in the form of tablets due to super potency, the U.S. Food and Drug Administration said in a statement.
The company is recalling one lot of 15-mg and one lot of 120-mg of NP Thyroid that are packaged in 100 count bottles in strengths of 15 mg, and 120 mg, with expiration dates between October 2020, and November 2020. The drug is originally intended to treat an underactive thyroid.
According to the company, the product may have as low as 87 percent of the labeled amount of Liothyronine (T4), it added.
NP Thyroid is composed of levothyroxine and liothyronine and used to treat hypothyroidism. 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 four reports of 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 May, Acella Pharmaceuticals had recalled 13 lots of hypothyroidism medication NP Thyroid in the form of tablets due to super potency.
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Article written by an RTT News Staff Writer, and posted on the RTT News.com website.
Article reposted on Markethive by Jeffrey Sloe