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More Metformin Recalls

Home » More Metformin Recalls
June 09, 2020
Edward Smith

Is Your Medication Included in the Metformin Recall?

If you are one of the millions of Americans with type two diabetes, you may be worried about recent news stories reporting on a metformin recall.  You may wonder if your medication is safe or not.   

Unfortunately, it can be challenging to figure out whether your particular batch is part of the metformin recall since pharmacies are not required to include lot numbers on pill bottle labels.  As such, a patient may not know that their specific pills have been recalled unless and until they are contacted directly by the pharmacy.  Because such communications usually go through the pharmacy’s main administration or corporate office, that notification could occur weeks or even months after the recall, if it occurs at all.

Reason for the Metformin Recall

The United States Food and Drug Administration (FDA) issued a recent announcement that certain extended-release formulas of metformin contained levels of N-Nitrosodimethylamine (NDMA) that were unacceptably high.  NDMA is known to be a probable human carcinogen.  Based on these findings, the FDA requested a voluntary recall of the products from multiple drug manufacturers.  Two such manufacturers, Apotex, Inc., and Amneal Pharmaceuticals, have recalled their extended-release metformin tablets in dosages of 500 and 750 milligrams.

The FDA has also requested that all companies that manufacture metformin pills test the batches before the medication is distributed.

It is not entirely clear how the substance found its way into medications but could form naturally during the manufacturing process.  It could also form during the packaging or storing phases.

What to Do if you Take Metformin

If you take metformin, do not suddenly stop taking it, but do verify with your pharmacist that the particular formulation you received is not part of the lots identified as being contaminated.  If it turns out that you do have contaminated medication, you should receive a refill of a formula that has been found to be safe during testing.

There is no need to panic since the overall risk associated with taking medicine that is contaminated with varying levels of NDMA is low.  However, it is important to discuss other treatment options with your physician.  There is no short-term risk, so keep taking the medication until you are able to speak with your doctor.  It is never a good idea to abruptly stop taking a prescribed medication without first consulting with your medical professional for supervision and direction.

What is NDMA?

NDMA is everywhere, essentially.  Low levels of the substance have been detected in vegetables, dairy products, meat, water, soil, and air.  According to the U.S. Environmental Protection Agency (EPA), the substance is created during industrial as well as natural processes that involve a chemical reaction. 

NDMA has been classified as a probable carcinogen in humans.  The cancer risk is thought to be increased if a person is exposed to NDMA at levels higher than 96 nanograms per day for an extended period of time.  It has been linked to diseases of the liver, kidneys, pancreas, gastrointestinal system, and colon.  

Below is an informative video uploaded by a pharmacist explaining the most recent metformin recalls.

Sacramento Personal Injury Lawyer

I’m Ed Smith, a personal injury lawyer in Sacramento, California.  I have been working on behalf of injured Northern Californians for more than 38  years.  If you have questions about an injury or a defective drug product, including those medications included within the metformin recall, reach out to my office at (916) 921-6400 within the local Sacramento region or (800) 404-5400 from outside the area. If you prefer electronic communication, submit our online form.

If you would like to take a minute to read what some of my prior clients have to say about our services, many reviews can be found at the sites listed below.

I have membership in the Million Dollar Forum and Top 1 Percent.  A sample of our case successes can be found here: Settlements and Verdicts.

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