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Septmeber 17, 2020: Acella Pharmaceuticals Issues Thyroid Tablet Recall Due To Sub Potency

Acella Pharmaceutical Thyroid Tablet Recall announced on September 17, 2020. Acella Pharmaceuticals, LLC recalled one lot each of the company’s 15-mg and 120-mg NP Thyroid®, Thyroid Tablets, after testing found these lots to be sub potent. The company stated that the product may have as low as 87% of the labeled amount of the medication, levothyroxine (T4).

Acella Pharmaceuticals issued the following risk statement as part of the thyroid tablet recall:

Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) 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. 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 Thyroid Tablet Recall Information

NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and are prescribed to treat hypothyroidism (underactive thyroid).

The recalled thyroid tablets are packed in 100-count bottles, and were distributed nationwide to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices.

The following lots are subject to the Acella thyroid tablet recall:

ProductNDCLot #Exp. Date
NP Thyroid® 15, Thyroid Tablets, USP, ¼ grain (15 mg)42192-327-01M327E19-1October 2020
NP Thyroid® 120, Thyroid Tablets, USP, 2 grain (120 mg)42192-328-01M328F19-3November 2020

According to the Acella announcement, the company is notifying its wholesalers by email and phone to discontinue distribution of the two recalled lots and that it is arranging for return of all recalled products.

The company urged that patients who are currently taking recalled NP Thyroid® should not discontinue use without contacting their healthcare provider for guidance and/or a replacement prescription. Consumers were also advised to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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