Acella Issues Yet Another NP Thyroid Recall
On April 29, 2021, Acella Pharmaceuticals issued yet another recall on NP Thyroid, this time due to subpotency. According to the FDA announcement, routine testing revealed that an eye-opening 35 commercial lots and three sample lots of NP Thyroid had less than 90 percent of the labeled amount of the active ingredients liothyronine (T3) and/or levothyroxine (T4). NP Thyroid is prescribed for those who suffer from underactive thyroid (“hypothyroidism”), so those patients who received the subpotent NP Thyroid may experience symptoms of hypothyroidism.
Symptoms of hypothyroidism include, but are not limited to, fatigue, constipation, hair loss, slow heart rate, depression, swelling of thyroid gland, and unexplained weight gain. Pregnant women may experience a miscarriage, or their newborn infants may suffer from hyperthyroidism and/or fetal development impairments. Elderly patients and those with underlying heart disease may experience heart symptoms of hyperthyroidism such as heart pain, palpitations, and rhythm disturbances (arrhythmias). Indeed, Acella is already aware of at least 43 reports of serious adverse events potentially linked to sub potent NP Thyroid.
This is just the latest in a series of recalls Acella has issued over the past year.
In May 2020, Acella recalled 13 lots of NP Thyroid due to the opposite problem – superpotency. As we reported in previous posts here and here, patients who ingest super potent doses of NP Thyroid may experience chest pain, rapid heart rate, heart rhythm disturbances, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, miscarriages, and impaired fetal development. Burg Simpson is currently investigating claims on behalf of several individuals potentially harmed by superpotent NP Thyroid.
Then in August 2020, the FDA sent Acella a strongly worded Warning Letter requiring Acella to run additional tests on its products to determine the strength of active ingredients in each product batch. It appears that further testing revealed additional manufacturing defects in Acella’s NP Thyroid production. In September 2020, Acella issued another recall on two lots of NP Thyroid because testing found them to be subpotent. The April 29, 2021 recall marks the third NP Thyroid recall Acella has issued since the beginning of 2020.
If you or a loved one have been injured by a defectively manufactured NP Thyroid, the nationally recognized Cincinnati dangerous drug attorneys at Burg Simpson can help. Burg Simpson has successfully represented thousands of individuals who suffered injuries due to defective drugs. We know what it takes to hold pharmaceutical companies responsible for their actions and secure just compensation for our clients. Call Burg Simpson’s product liability attorneys in Cincinnati, Ohio office today at 513-852-5600 or fill out our free case evaluation form now to discuss your case with us.