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Acella Pharmaceuticals thyroid medication under voluntary recall
Acella Pharmaceuticals, LLC recalled NP Thyroid tablets after testing found the lots to be subpotent, the FDA said in a Sept. 17, 2020 notice.
WASHINGTON - Thyroid medication has been voluntarily recalled after testing indicated that the tablets may not be strong enough, according to the U.S. Food and Drug Administration.
Acella Pharmaceuticals, LLC recalled one lot of 15 milligram NP Thyroid tablets and one lot of 120 milligram NP Thyroid tablets after testing found the lots to be “sub potent,” an FDA statement reads.
“The product may have as low as 87% of the labeled amount of levothyroxine,” the notice states.
Acella Pharmaceuticals, LLC recalled one lot of 15 mg NP Thyroid tablets and one lot of 120 mg NP Thyroid tablets. (Photo credit: FDA)
The FDA said patients being treated for hypothyroidism, or an underactive thyroid, and who received a sub potent NP Thyroid prescription, could "experience signs and symptoms of hypothyroidism, which may 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."
“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,” the statement continued. “In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.”
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The FDA said there have been at least four reports of adverse effects to date involving the lot numbers, possibly related to the recall.
NP Thyroid, Thyroid Tablets, USP is made of of levothyroxine and liothyronine and used to treat hypothyroidism. The products subject to recall are packed in 100-count bottles.
The impacted medication was distributed nationwide to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices, the notice said.
The recalled 15 mg tablet has lot number M327E19-1, an expiration date of October 2020 and NDC number of 42192-327-01.
The recalled 120 mg tablet has lot number M328F19-3, an expiration date of November 2020 and NDC number of 42192-328-01.
This story was reported from Cincinnati.