NP Thyroid May 2020 Recall
On May 22, 2020, Acella Pharmaceuticals, LLC issued a voluntary national recall of specific lots of their NP Thyroid (Thyroid Tablets, USP) medication. NP Thyroid is used to treat hypothyroidism using a combination of hormones—levothyroxine and liothyronine. In total, 13 lots of 30mg, 60mg, and 90mg of the drug were recalled due to super potency found within the medication. The lots were found to contain up to 115% of the labeled amount of the hormone liothyronine (T3).
Patients who are being treated for hypothyroidism (underactive thyroid) with the medication and consume the lots of super potent medication may experience signs and symptoms of hyperthyroidism (overactive thyroid).
Symptoms of Hyperthyroidism (Overactive Thyroid)
- Weight loss
- Heat intolerance
- Muscle weakness
- Chest pain
- Rapid heart rate
- Heart rhythm disturbances
Pregnant women who consume a super potent lot may experience negative maternal and fetal outcomes, which can include miscarriage and/or impairment to fetal development.
At the time of the recall, Acella Pharmaceuticals had received two reports of adverse events caused by the super potent lots of the medication.
FDA Investigates Acella Pharmaceuticals for Lax Controls
The FDA issued a warning letter to Acella Pharmaceuticals in August 2020 after quality control issues were discovered in their manufacturing process that ultimately led to the recall of NP Thyroid medications in May 2020.
The FDA investigated the company between December 2019 and January 2020 and determined that Acella failed to use appropriate safety evaluations for active pharmaceutical ingredients (API) used in the NP Thyroid drug. Some of these API’s had been provided to Acella by third party contract manufacturers. However, the FDA regards contractors as an extension of manufacturer and ultimately the manufacturer is responsible for the safety of the ingredients added to its products. The FDA’s investigation found 13 lots of NP Thyroid that exceeded the specified strength—these lots were deemed to be super potent and led to the May 2020 recall.
In its warning letter, agency determined that Acella did not have proper safety protocols in place to evaluate the quality of ingredients provided by its third party contractors, which led to the super potent lots of NP Thyroid being improperly distributed.
The investigation also uncovered that Acella had failed to pursue a long-term stability study for lots of NP Thyroid produced by its CMO and a new API supplier in May 2019. This means that almost a year after the drugs were manufactured, validation batches of the drug had not been studied for long-term potency. This creates concerns for the shelf life of the medication. The FDA said that due to the “narrow therapeutic range” of NP Thyroid, out-of-spec dosing could pose serious side effects for patients.
NP Thyroid September 2020 Recall
On September 17, 2020, Acella Pharmaceuticals issued another voluntary nationwide recall of two lots of NP Thyroid (Thyroid Tablets, USB), this time due to sub potency. Testing revealed that the recalled lots had as low as 87% of the labeled amount of the levothyroxine (T4) hormone needed as part of the combination levothyroxine (T4) and liothyronine (T3) medication.
Patients who are being treated for hypothyroidism (underactive thyroid) and receive a sub potent lot of the medication may experience symptoms of hypothyroidism.
Symptoms of Hypothyroidism (Underactive Thyroid)
- Increased sensitivity to cold
- Dry skin
- Puffy face
- Hair loss
- Slow heart rate
- Swelling of the thyroid gland
- Unexplained weight gain
- Difficulty losing weight
So far, Acella Pharmaceuticals has received four reports of adverse events likely related to the recall.
What Does the Thyroid Do?
The thyroid is an endocrine gland located at the base of the neck and produces two hormones—levothyroxine (T4) and liothyronine (T3). The thyroid works to regulate the body’s temperature, and help control other process such as hair and nail growth, the speed at which food is metabolized, and heart rate.
Hypothyroidism vs. Hyperthyroidism
Hypothyroidism is a condition that occurs when the thyroid is underactive. Basically, the thyroid gland does not produce enough of the T3 and T4 hormones. If a person does not have enough of these hormones, bodily processes begin to slow down. The body produces less energy and metabolism becomes slower. The most common cause of hypothyroidism is Hashimoto’s thyroiditis which is the inflammation of the thyroid gland. Other common causes include the surgical removal of the thyroid and radiation treatment.
Hyperthyroidism occurs when the thyroid is overactive. Therefore, the thyroid produces too much of the T3 and T4 hormones. This can result in the body’s metabolism increasing and can cause unintentional weight loss and a rapid or irregular heartbeat.
How GoldenbergLaw Can Help
The Minnesota Defective Drug Attorneys at GoldenbergLaw have been helping clients receive justice for over thirty years. Contact us today for a free thyroid medication recall lawsuit consultation and leave the sleepless nights to us!