Acella Pharmaceuticals, LLC recalled certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level.
The affected products were recalled due to the results from the samples that were tested by the U.S. Food and Drug Administration (FDA).
The FDA found the samples to be sub-potent. The results showed the products to have as low as 90% of the labeled amount of Liothyronine or Levothyroxine.
According to the FDA, patients with hypothyroidism who take sub potent Nature-Throid or WP Thyroid, may experience signs and symptoms of hypothyroidism, which may 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.
The product was distributed nationwide in the United States.
Acella has taken the necessary precautions to ensure the safety of consumers by notifying its distributors and consumers by emails, phone call and letters.
The company is also arranging for the refund of all voluntary recalled products.
Acella encourages patients that are taking the recalled medications to continue taking them and to contact their local pharmacist, physician or medical provider for advice regarding an alternative treatment.
There have been no reports of adverse reactions due to the recalled products thus far.