DESSICATED THYROID RECALL

WEBMD HEALTH NEWS

Some Thyroid Drugs Recalled Over Reduced Potency

By Nancy Melville

May 04, 2021 — In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular thyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be less potent than what the label says.

ADVERTISEMENT

Specifically, the affected lots were found to contain less than 90% of the drug’s two labeled ingredients to treat hypothyroidism: liothyronine (LT3) and/or levothyroxine (LT4).
The recalled lots include 15 mg, 30 mg, 60 mg, 90 mg and 120 mg pills packed in 100-count and 7-count bottles.
See the full list of recalled drugs on the FDA website.
There have been 43 reports of serious problems in patients that could be related to the recall.
Signs you may have one of the recalled drugs include the common signs of hypothyroidism, such as 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, Acella reports.

“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 company cautions in the recall statement.
Acella adds that toxic heart problems related to hyperthyroidism, including chest pain, heart palpitations or irregular heartbeat may happen in elderly patients and patients with heart disease.
While Acella is working to stop distribution of the recalled products, patients who are currently taking these medications should keep taking them and contact their doctor for further guidance.
In November, the same drugs were recalled for having lower-than-specified potency.
And in May 2020, the company recalled 13 lots of the tablets that were overly potent, with FDA testing showing some tablets contained up to 115% of the labeled amount of LT3.
If you have questions about the recall, email Acella Pharmaceuticals at recall@acellapharma.com or call 888-424-4341, Monday through Friday from 8 a.m. to 5 p.m. ET.

WebMD Health News from MDedge

Published by Dr. Gervais Harry

I am a Toronto-trained Urologist. I practiced in downtown Toronto, from 1977 to 1997, when I went to Saudi Arabia as chief of Urology at the Armed Forces (teaching) hospital in Tabuk. Returning to Toronto in Y2000, I switched to family practice. In 2007, began to prescribe Hormone Restoration Therapy and in 2012, I became a member of the American Academy of Antiaging Medicine [A4M]. I successfully wrote the A4M's written examination in December, 2013 and In May, 2016 I passed the oral examination, for accreditation as a BHRT consultant. In 2014 I began BHRT practice in Collingwood, Ontario and in January, 2017, joined the Stone Tree Naturopathic Clinic. Now I am 82 and have retired, but it seems wasteful to jettison my learning and experience: the medical establishment knows nothing of BHRT / Functonal medicine and I feel obliged to offer my knowledge in the interest of those who are willing to think outside the box. MY QUALIFICATIONS: MB, BS, (from UWI), 1964. LMCC 1969. FRCSC (Urology), 1974. ECFMG 1984. Florida license 1998 [inactive], ABAARM Certification [A4M], 2016. I am a Member of CSAMM [the Canadian Society for Aging and Metabolic Medicine], the OMA&CMA, SUSO, CUA, RCP&S/C. PRACTICE TO DATE: Consultation in Functional Medicine, including assessment of Chronic Fatigue Syndrome, Fibromyalgia, Andropause, Menopause, Teenage and Postpartum Depression/Panic Attacks, Thyroid Hormone malfunction, Infertility, Sexual Dysfunction and “the Undiagnosable”. ALL ARE WELCOME to read, comment or question!

Leave a Reply

%d bloggers like this: