Acella Recalls 2 Lots of Thyroid Medication for Subpotency
Two lots of the thyroid tablets are being recalled after testing found the lots to be subpotent.
Acella Pharmaceuticals has issued a voluntary recall of 1 lot of 15-mg and 1 lot of 120-mg NP Thyroid, thyroid tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level because of subpotency.
Thyroid tablets, USP is used for the treatment of hypothyroidism. The products being recalled are packed in 100-count bottles.
According to the company announcement, the products are being recalled after testing found the lots to be subpotent, indicating that the product may have as low as 87% of the labeled amount of levothyroxine.
Patients with hypothyroidisim who receive subpotent thyroid tablets, USP 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. Additionally, there is a reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism, and elderly patients and those with underlying cardiac disease may experience toxic cardiac manifestations of hypothyroidism.
To date, Acella has received 4 reports of adverse events for these lot numbers possibly related to this recall.
The manufacturer is proactively notifying its wholesalers to discontinue distribution of the affected its and is arranging for return of all recalled products. Patients who are currently taking the thyroid tablets from the recalled lots should not discontinue use without contacting their health care provider for further guidance and/or a replacement prescription.
Reference
Acella Pharmaceuticals. LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency. Company announcement. FDA; September 17, 2020. Accessed September 22, 2020. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-two-lots-np-thyroidr-thyroid-tablets
