Acella Pharmaceuticals can’t seem to get its correct thyroid medication.
Acella recalled a whopping 35 commercial lots and three sample lots of NP Thyroid drug, used to treat underactive thyroid, for underpowering. Testing revealed that these lots contained less than 90% of the active ingredients Liothyronine (T3) and / or Levothyroxine (T4) as stated on the bottle labels.
If this sounds familiar to you, Acella recalled some lots of NP Thyroid for underpower in September 2020 and several lots of the drug at the end of May 2020 for “super potency”.
No more thyroid drugs recalled to be too weak. People have reported issues
A prescription drug was recalled for “super potency”. The patients had problems
“To date, Acella has received 43 reports of serious adverse events that could potentially be related to this recall,” said the recall notice written by the company and published by the FDA.
Symptoms of problems with the NP Thyroid drug that are not as strong as claimed, according to the recall notice, include “fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss , slow heartbeat, depression, swelling of the thyroid gland and / or unexplained weight gain or difficulty losing weight. “
It also states that there is “a reasonable risk of serious injury in newborns or pregnant women with hypothyroidism” via early miscarriage, fetal hyperthyroidism, possible problems with newborn nerve and bone development. .
“In elderly patients and patients with underlying heart disease, toxic cardiac manifestations of hyperthyroidism may occur, such as heart pain, palpitations, or cardiac arrhythmia.”
The recall notice lists the recalled lots, which are in 100-dose vials of 15 mg, 30 mg, 60 mg, 90 mg and 120 mg tablets and in seven-count vials of 15 mg sample lots, 30 mg and 120 mg. tablets.
If this or any other medication is causing a medical problem, after notifying a healthcare practitioner, notify the Food and Drug Administration through its MedWatch Adverse Event page or by filling out a form which you can obtain by calling the 800-332-1088. Only then do you call the manufacturer.
If you have any questions regarding the recall, contact Acella at email@example.com or 888-424-4341, Monday to Friday, 8 a.m. to 5 p.m. EST.