Acella Pharmaceuticals does not seem to get that thyroid medication right.
Acella recalled as many as 35 commercial batches and three test batches of NP thyroid medication used to treat underactive thyroid glands to sub-potency. Testing showed that these batches 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 remembered certain masses of NP thyroid for sub-potency in September 2020 and several batches of the drug in late May 2020 for “superpotency.”
“To date, Acella has received 43 reports of serious side effects that may be related to this recall,” the company-written recall notice from the FDA said.
Symptoms of NP thyroid medication problems that are not as strong as claimed, the recall says, include “fatigue, increased sensitivity to cold, constipation, dry skin, swollen 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 is a “reasonable risk of serious injury in newborns or pregnant women with hypothyroidism” via premature abortion, 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 shows the recalled batches that are in 100 bottles of 15 mg, 30 mg, 60 mg, 90 mg and 120 mg tablets and seven counter bottles with sample batches of 15 mg, 30 mg and 120 mg strength tablets.
If this or any drug causes a medical problem, after notifying a physician, notify the Food and Drug Administration via its MedWatch adverse reaction page or by filling out a form available by calling 800-332-1088. Only then do you call the manufacturer.
For questions about the recall, contact Acella at email@example.com or 888-424-4341, Monday through Friday at 8 to kl. 17, Eastern time.