Acella Pharmaceuticals, LLC has recently issued a voluntary recall of 38 lots of NP Thyroid, Thyroid Tablets, USP after routine testing found these lots to be subpotent. The recalled lots of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg tabs contain less than 90% of the labeled amount of liothyronine and/or levothyroxine.
Patients who have received the these sub potent drugs may experience signs and symptoms of hypothyroidism (underactive thyroid) including fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland, and unexplained weight gain or difficulty losing weight.
There is a reasonable risk of injury to newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hypothyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism (overactive thyroid) may occur, such as cardiac pain, palpitations or arrhythmia.
To date, Acella has received 43 reports of serious adverse events that are potentially related to the recall. If you are a patient taking any of the affected lots of NP Thyroid and have experienced severe side effects, don’t wait to contact the team of experienced attorneys at Cellino Law. Call our team of experienced attorneys at 800-555-5555 for your free case consultation.
NP Thyroid Recall Lawsuits
When pharmaceutical makers distribute defective medications, patient injury may be a consequence. On April 29, 2021, Acella Pharmaceuticals informed the Food and Drug Administration of a voluntary recall for 38 lots of Thyroid NP. These recalled lots may have shipped with potency as much as 10% below the label listing.
This announcement marks the third recall for Thyroid NP lots in less than a year. In May 2020, the drug maker announced a recall of 13 lots for potency 15% above the product’s labeled amount. In September 2020, Acella recalled two lots for potency 13% under the label amount.
Thyroid NP treats hypothyroidism, a condition where the thyroid gland produces an inadequate amount of two essential hormones. Without treatment, hypothyroidism can lead to mental health issues and heart problems.
Possible Adverse Events
As of the announcement date, Acella acknowledged 43 adverse event reports possibly linked to the low-potency lots under recall. Symptoms consistent with these reports include:
- Weight gains
- Reduced heart rate
- Greater sensitivity to cold
- Hair loss
Pregnant women may face additional risks. Acella acknowledged a higher risk for miscarriage, fetal development impairments and fetal hypothyroidism.
With elderly patients or persons with cardiac disease, consuming the recalled lots may have led to palpitations, chest pain or an uneven heartbeat.
Action Steps for Patients
Lot numbers and product labels for the recalled lots are available on the FDA’s announcement web page. Patients can find their prescription lot numbers on their pharmacy receipts. If you do not have your receipts, you can ask your pharmacy for copies.
Acella and the FDA caution patients against discontinuing Thyroid NP if their medications are among the recalled lots. Instead, patients should request a replacement prescription from their physicians. Persons who consumed one of the recalled lots and suffered adverse effects may wish to consult with a personal injury attorney.
Do I Need a Lawyer if I Experienced Side Effects?
The side effects of an incorrect thyroid medication dosage can directly affect one’s quality of life. The ability to focus, productivity on the job or caliber of schoolwork may suffer as a result.
Additionally, other consequences can harm a person’s general physical and emotional health. When people discover that a pharmaceutical manufacturer sold thyroid medicine at a lower than stated dosage, hiring a lawyer may be ideal.
Is There a Need for Compensation?
A person who experiences dangerous and unexpected side effects from a drug has the right to seek compensation. The purpose of filing a claim is to obtain financial restitution for the losses and damages resulting from adverse consequences that came without warning. The same is true when a person suffers the harmful results of underdosing.
Such restitution can help pay for medical bills, legal fees, lost wages, pain, suffering and other associated costs of dealing with the side effects. This type of compensation might also incentivize drug companies and medical providers to ensure their products and treatments are safe, reducing instances of injured persons in the future.
Can a Lone Plaintiff Contend Against a Robust Legal Team?
Fighting a case against a large corporation with a legal department can be daunting. The entity often has the financial resources and background to outmaneuver an individual who sues them. For example, Acella Pharmaceuticals has executive leadership with decades of experience in legal matters.
Further, the size of many drug companies means they have access to influential networks of legal professionals. These contacts may share experience and techniques for defending cases and prolonging settlements, making it challenging to resolve a suit promptly.
A person who wants to battle a large company can locate a firm with decades of experience and a track record of successful settlements. With additional assistance on the plaintiff’s side, a person who received the incorrect dosage of a thyroid drug may be able to get compensation to deal with the aftereffects.