Acella Pharmaceuticals announced the voluntary recall of 1 lot of NP Thyroid® (levothyroxine and liothyronine) 15mg and 1 lot of NP Thyroid 120mg as testing revealed that the product may have as low as 87% of the labeled amount of levothyroxine.
NP Thyroid is indicated for the treatment of hypothyroidism. In a statement, the Company noted that “patients being 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.”
The recalled products, which were distributed nationwide in 100-count bottles, include:
- NP Thyroid 15mg; NDC 42192-327-01; Lot # M327E19-1; Exp Date October 2020
- NP Thyroid 120mg; NDC 42192-328-01; Lot # M328F19-3; Exp Date November 2020
Patients with prescription bottles labeled with a “use by”, “discard after” or “expiration date” on or after December 2020 are not impacted by this recall.
At this time, Acella has received 4 reports of adverse events associated with these lots. Any adverse events related to this recall should be reported to the FDA’s MedWatch program.
For more information contact Acella Pharmaceuticals at (888) 280-2044 or email [email protected].
Acella Pharmaceuticals, LLC issues voluntary nationwide recall of two lots of NP Thyroid®, thyroid tablets, USP due to sub potency. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-two-lots-np-thyroidr-thyroid-tablets. Accessed September 21, 2020.
This article originally appeared on Endocrinology Advisor