Acella recalls some levothyroxine tablets due to subpotency
Acella Pharmaceuticals is voluntarily recalling one lot of 15 mg and one lot of 120 mg levothyroxine and liothyronine tablets due to subpotency, according to an FDA announcement.
The levothyroxine and liothyronine tablets (NP Thyroid) are being recalled because testing has found they may have as low as 87% of the labeled amount of levothyroxine, according to the agency announcement.
Patients treated for hypothyroidism who receive subpotent NP Thyroid may 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, according to the FDA. 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 older adults and patients with underlying cardiovascular disease, “toxic cardiac manifestations” of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.
“To date, Acella has received four reports of adverse events for these lot numbers possibly related to this recall,” the FDA stated in the announcement.
The tablets are composed of levothyroxine and liothyronine and used to treat hypothyroidism. The products subject to recall are packed in 100-count bottles.
The products recalled are these:
- NP Thyroid 15 mg; NDC #42192-327-01; Lot# M327E19-1; expiration date, October 2020; and
- NP Thyroid 120 mg; NDC #42192-328-01; Lot# M328F19-3; expiration date, November 2020.
Additionally, consumers may be able to determine that their product is not impacted by the recall if the “use by,” “discard after,” or “expiration date” on their prescription bottle is on or after December 2020, according to the FDA.
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