Acella Pharmaceuticals can’t seem to get its thyroid medicine right.
Acella recalled a whopping 35 commercial lots and three sample lots of NP Thyroid medicine, used to treat underactive thyroids, for sub-potency. Testing found these lots had less than 90% of the active ingredients liothyronine (T3) and/or levothyroxine (T4) as claimed on the bottle labels.
If this sounds familiar, Acella recalled certain lots of NP Thyroid for sub-potency in September 2020 and several lots of the drug in late May 2020 for “super potency.”
“To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall,” the company-written, FDA-posted recall notice says.
Symptoms of problems from NP Thyroid medicine that’s not as strong as claimed, the recall notice says, 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.”
It also says there’s “reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism” via early miscarriage, fetal hyperthyroidism, possible problems with newborns nerve and bone development.
“In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.”
The recall notice lists the lots recalled, which are in 100-count bottles of 15 mg, 30 mg, 60 mg, 90 mg and 120 mg strength tablets and seven-count bottles of sample lots of 15 mg, 30 mg and 120 mg strength tablets.
If this or any drug causes a medical problem, after notifying a medical professional, let the Food and Drug Administration know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088. Only then do you call the manufacturer.
For questions about the recall, contact Acella at [email protected] or 888-424-4341, Monday through Friday, 8 a.m. to 5 p.m., Eastern time.