Acella Pharmaceuticals recently recalled 35 commercial lots and three sample lots of NP Thyroid medicine after testing revealed sub-potency of the medication prescribed to treat underactive thyroids. Testing discovered that the recalled lots had less than 90% of the active ingredients liothyronine (T3) and/or levothyroxine (T4) as claimed on the bottle labels.
This most recent recall comes after two previous recalls in 2020. The FDA recalled specific lots of NP Thyroid for sub-potency in September 2020. Earlier in May 2020, several lots were recalled for super potency.
In addition, Acella has received 43 reports of serious adverse events that could be related to the latest recall, according to the recall notice via the Food and Drug Administration.
With the sub-potent NP Thyroid medicine, people reported symptoms that 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 notice also stated that there is a reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism that could result in early miscarriage, fetal hyperthyroidism, and possible problems with newborns’ nerve and bone development.
Elderly patients and patients with underlying cardiac disease may experience symptoms of hyperthyroidism, including cardiac pain, palpitations, or cardiac arrhythmia.
The FDA recall notice lists the exact lot numbers affected. The lots come in 100-count bottles of 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg strength tablets and seven-count bottles of sample lots of 15 mg, 30 mg, and 120 mg strength tablets.
Actions to Take After a Drug Recall
Both prescriptions and over-the-counter medications are thoroughly tested for safety and effectiveness before doctors can prescribe them to patients. Once on the market, drugs are monitored for unforeseen problems. The FDA will issue a recall when a drug is found to be defective, poses a side effect that was not initially apparent, or may be harmful.
Drug recalls occur frequently for minor problems. Sometimes, medications may contain toxic impurities or incorrect levels of active ingredients, like in this recent case with Acella. Here is how you should handle drug recalls if a medicine you are taking is affected:
- Stop taking a recalled drug immediately. You may be able to return the product to where you purchased it and ask for a refund. Ask the store about their recall refund policy.
- Contact a health professional if necessary. If one of your prescription medications is recalled, call your physician or pharmacist to learn more about a replacement medication.
- Learn more about the recall. Find regularly updated recall information from the FDA on its website and sign up for product recall alerts.
- Safety discard of the recalled drug. See instructions for safe disposal on the medication’s label or package’s patient information. Contact your local pharmacy and ask if they offer a medication disposal service, as many major pharmacies now offer this service.
- Report medical problems to the FDA. After notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
- Explore additional assistance. Dangerous and defective drugs may pose a major product liability issue. Depending on the case, drug manufacturers have been held liable for adverse side effects and found negligent if mistakes occurred during product testing or production.
Product Safety Liability
Drug manufacturers are responsible for creating medications that are safe for the people they are designed to help. Many times there are dangers and risks that cannot be eliminated from product design, but manufacturers must still inform consumers of these inherent risks. They are also required to provide reasonable warnings in cases where unanticipated dangers may be avoided. Sometimes, manufacturers may be held responsible even when dangers are unforeseen.
Product liability lawsuits play an important role in keeping our families and communities out of danger because they hold manufacturers accountable for the safety of their products. If you or someone you love has been injured by a defective medication or harmful product, our team of attorneys at Panter, Panter & Sampedro may be able to help you fight back against the manufacturers and recover damages. Product liability cases require experienced legal teams who know how to navigate technical issues and can help you determine if a product liability case is your best option. Contact our team for a free consultation today at (305) 662-6178.
Acella Pharmaceuticals, LLC. (April 29, 2021). Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency. Retrieved from: https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid-0
Neal. (May 2, 2021). A thyroid medicine’s third recall: It’s too weak and 43 people had ‘serious problems. Retrieved from: https://miamiherald.com/news/health-care/article251108814.html
C.DerSarkissian. (January 16, 2020). What Is a Drug Recall? Retrieved from: https://webmd.com/a-to-z-guides/what-is-a-drug-recall