The U.S. Food and Drug Administration, FDA, announced a broad recall of the widely used type 2 diabetes medication Metformin. The agency issued the recall after multiple manufacturers of this medication advised the FDA that certain types of Metformin tablets were found to contain unacceptably high levels of what is known as NDMA. Scientifically, NDMA is also known as
N-Nitrosodimethylamine or dimethylnitrosamine and is classified as a cancer-causing or carcinogenic substance.
Metformin is used by individuals with type 2 diabetes as a means of lowering their glucose levels. Metformin is particularly “popular” because it is proven highly effective at lowering glucose levels but doesn’t drop them beyond a healthy level. The medication comes in both regular release and extended time-release formulations. The extended time-release derivations of the medication are what is now subject to the FDA recall.
The recall specifically includes Metformin sold under the brand name Time-Cap (Time Cap Labs). The recalled medication includes 500 mg to 750 mg extended time-release tablets. The recalled tablets have either 101 or 102 embossed on one side while there is nothing on the reverse side.
The FDA has identified specific lots that appear to be contaminated with dangerous levels of NDMA. These are:
The Metformin recall discussed here is only the latest one involving extend time-release tablets thought to be contaminated with NDMA. Recalls associated with this medication began in earnest in the summer of 2020, involving a number of different manufacturers of Metformin.
If you have type 2 diabetes and have been taken Metformin and have not received a notification about the recall, you need to contact your primary care physician or your pharmacist to confirm that your medication is not subject to a recall. You do need to check the imprint on your tablets to ascertain if it is an embossed 101 or 102. As noted, these are the numbers associated with the recalled tablets.
Even if you do not use tablets marked 101 or 102, you are still wise to consult with your doctor or pharmacist out of appropriate caution. The same holds true if you use regular dose tablets as opposed to the extended time-release derivation. In this way, you will have added peace of mind knowing your medication is not under scrutiny for contamination, at least as of this time.
The FDA and the various drug manufacturers are only now in the midst of investigating how the NDMA contamination in the extended time-release Metformin tablets occurred. In addition, there currently is no firm data available pertaining to how many type 2 diabetes patients have been impacted by the Metformin recall. The number is certainly in the thousands, if not the tens of thousands of people in the U.S.A. with type 2 diabetes.
If you or a member of your family have been using a time-released Metformin product and have concerns about your legal rights, a pharmaceutical litigation lawyer from The Doan Law Firm is available any time to discuss your case. You can schedule an initial consultation with a pharmaceutical litigation lawyer from our firm any time of the day or night by calling us at (800) 349-0000. Out pharmaceutical litigation lawyer telephone line is staffed 24 hours a day, 365 days a year, including all major holidays. The bottom line is that we are always here for you.
A nationwide law practice, our firm has 40 offices located from coast to coast. We can schedule an appointment to discuss your Metformin matter – or any other prescription issue – at any one of our firm’s offices. We can also arrange a virtual case consultation with you online. There is no charge nor any obligation for an initial consultation with a pharmaceutical litigation attorney from our firm.
The Doan Law Firm makes an attorney fee promise to you. Our firm will never charge an attorney fee unless we win for you. Our commitment is to fight hard for the compensation you deserve as a result of injuries sustained because of an issue with your medication.
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