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Amended: Acella Pharma Recalls Thyroid Drug For Super Potency

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The U.S. Food and Drug Administration or FDA announced that Acella Pharmaceuticals, LLC recalled certain lots of hypothyroidism medication NP Thyroid in the form of tablets due to super potency.

The company is recalling 13 lots of NP Thyroid that are packaged in 100 count bottles in strengths of 30 mg, 60 mg, and 90 mg, with expiration dates between June 20, 2020, and December 20, 2020. The drug is originally intended to treat an underactive thyroid.

The pharma company said, "The products are being recalled because our testing has found these lots to be super potent." The products may have up to 115 percent of the labeled amount of Liothyronine (T3), it added.

The company noted that if patients are treated for hypothyroidism with these super potent NP Thyroid tablets, they may experience signs and symptoms of hyperthyroidism which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances.

Further, pregnant women who take super potent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development.

Acella Pharmaceuticals said it has received two reports of adverse events to date related to the recalled products.

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.

The company said it is arranging for the return 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 for further guidance and/or a replacement prescription," the company added.

(Corrects and replaces the last paragraph to say patients are urged not to discontinue taking medication)

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