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In a company-wide announcement in January 2022, Viona Pharmaceuticals, Inc. announced a voluntary recall of 33 lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg at the consumer level. The Metformin recall comes after the presence of N-nitrosodimethylamine (NDMA) in an Out of Specification (OOS) testing result.
Based on laboratory testing, N-nitrosodimethylamine (NDMA) is a probable human carcinogen or cancer-causing agent. According to the Food and Drug Administration, NDMA is a known environmental contaminant found in water and foods including but not limited to meats, dairy, and vegetables.
It is important to note that the impacted lots of Metformin place patients at an increased risk of cancer.
If you are a patient who became ill or has concerns about the Metformin recall, or any other drug recall, the product liability attorneys at Regan Zambri Long can help.
Metformin is commonly used alone or in conjunction with other medications such as insulin to treat type 2 diabetes. As part of the class of drugs called biguanides, Metformin helps control the amount of sugar, or glucose, in the blood by decreasing the amount of glucose absorbed from food and the amount of glucose made by the liver.
Further, Metformin can help restore the body’s ability to respond to insulin.
Metformin comes in three forms: as a liquid, a tablet, and an extended-release tablet to take by mouth.
If you have an impacted lot of Metformin, you are advised to continue taking your medications but to consult with a medical provider on alternative treatment options.
To date, no adverse events have been reported to Viona Pharmaceuticals, Inc. or Cadila Healthcare Limited which manufactures Metformin.
In addition, Viona Pharmaceuticals, Inc. has notified customers by mail and email to alert them of the product recall.
It is important to note that the recall does not impact all types and brands of Metformin. If you are unsure of where your medication comes from, contact your pharmacist.
You can review which lots of Metformin have been recalled here.
Metformin is commonly used to treat type 2 diabetes. Metformin is not for use by patients who have type 1 diabetes.
Metformin may also be used off-label for prediabetes, gestational diabetes, and polycystic ovary syndrome (PCOS).
It is estimated that one in two Americans take at least one prescription medication. Knowing this, it is not a shock that in your lifetime, a medication you or a loved one takes may become subject to an FDA recall.
If you have been prescribed Metformin or another prescription medication that has since been recalled, there are a few steps you should take to protect yourself from harm.
First, you should not panic if a drug or medical device you take or use is recalled. Often, FDA recalls are made out of an abundance of caution to ensure consumer safety.
Depending on the medication you are taking, you may be able to stop the medication immediately and be placed on a replacement medication. However, in the case of Metformin, do not stop taking your medication until you have spoken to your medical provider. From there, a doctor or pharmacist will be able to place you on a new regimen or replace the current medication with a safe lot.
Further, you should read all recalled information that has been provided to you. This is of particular importance if the medication you are taking has reported side effects and decreases in efficacy. If you experience one or more of the side effects listed in the recall, contact your medical provider right away.
Next, you will want to follow the recall protocol. In some cases, you may be asked to dispose of the medication with your local pharmacy or to send it back to the manufacturer. No matter what you do, be sure to place the medication out of reach from small children and animals.
Finally, be diligent and mindful with all medications for changes in appearance, taste, or color even if the medication has not been recalled.
A voluntary recall may seem like it is not as serious as other forms of immediate recall. However, a voluntary recall is actually beneficial to consumers as it helps recall products quickly before widespread issues emerge.
It is estimated that 14 drugs have already been recalled since the beginning of 2022.
Specifically, the presence of N-nitrosodimethylamine (NDMA) has been prevalent in not just Metformin, but numerous other prescription medications.
Impacted drugs include:
N-nitrosodimethylamine (NDMA) is more common than we realize, being found in a variety of products and foods including tobacco, cured meats, fermented foods, shampoo, cleansers, detergents, and pesticides.
But how does it end up in medication?
NDMA is a compound that appears typically because of a cooking or fermenting process taking place.
However, pharmaceutical companies and scientists are now saying that the manufacturing process or the conditions in which these compounds are stored and packaged can be creating the presence of NDMA.
However, in the case of Metformin, how NDMA is appearing is still uncertain.
Because of this, the FDA and scientists are looking into the entire supply chain from the compounds themselves to the packaging used to store the medications.
When you utilize a drug or medical device, it is supposed to improve your quality of life, not hinder it. Unfortunately, drug and medical device recalls happen all the time, leaving many patients feeling confused and lacking faith in medicine.
If you or a loved one has been diagnosed with cancer after the use of Metformin, contact Regan Zambri Long. Our dangerous drug lawyers will protect your rights to determine if the product caused or contributed to your sickness.
If you have a successful product liability claim, you may be able to collect compensation for medical bills, lost wages, diminished earning capacity, etc. Further you may also be able to collect non-economic damages for pain and suffering, diminished quality of life, and loss of companionship in the case of wrongful death.
In very rare cases, punitive damages may be collected when the at-fault party acted with negligence or malice.
Whom you will collect damages from depends on who caused the suffering. The drug manufacturer, lab, marketing team, etc. could be found at fault for dispensing the drug.
With more than 100 years of combined experience, our lawyers know that when medications intended to help patients cause more harm, justice must be served. Our team works alongside industry experts to understand where the issues occurred, be it in the manufacturing like the case of Metformin recall, storing, or creation of prescription drugs, and why it went under the radar for so long.
For a no-obligation, free consultation, contact the product liability lawyers at Regan Zambri Long at (202) 960-4596 or contact us online.
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