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Metformin bottle with a pharmacy label
Chaffin Luhana LLP
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A New York plaintiff recently filed a metformin class-action lawsuit on behalf of himself and all others who took the type 2 diabetes medication manufactured by Ascend Laboratories. The plaintiff claims that the defendants market their medication as safe, but based on scientific findings submitted by online pharmacy Valisure, the medication may contain the carcinogenic impurity, “N—nitrosodimethylamine (NDMA).”

Plaintiff Seeks to Represent All Patients Who Took Ascend’s Metformin

The plaintiff has been taking metformin since 2011. He writes in his complaint that when purchasing the medication, he reviewed the accompanying labels and disclosures, and understood from the representations and warranties by the manufacturer that the medications were properly manufactured and free from defects. He relied on these warranties in assuming the product was safe.

The plaintiff first learned that metformin may be contaminated with NDMA from the news media.  He now seeks to represent a class of all those in the U.S. who purchased metformin manufactured by Ascend.  He also seeks to represent a subclass of all class members who purchased the drug in New York.

He brings counts of breach of warranties, unjust enrichment, fraudulent concealment, fraud, conversion, and violation of business laws. He seeks class-action status for the case, as well as compensatory, statutory, and punitive damages.

Valisure Challenges FDA’s Findings on NDMA in Metformin

On March 20, 2020, online pharmacy Valisure—which was the first to detect NDMA in samples of ranitidine (Zantac)—discovered elevated levels of NDMA in specific lots of the drug metformin.  The pharmacy analyzed 22 companies selling metformin and a total of 38 batches.  They found that 16 batches from 11 companies had NDMA at levels above the 96 nanograms the FDA has deemed to be acceptable.  Several batches contained over 10 times that level.

Valisure then filed a citizen’s petition with the FDA informing them of the findings. In the petition, the company asked the FDA to recall the identified batches of metformin, investigate manufacturing processes, inform the public of the problem, and issue guidance for future testing and verification of metformin products.

Prior to these findings, in early 2020, the FDA had released its own test results.  The agency did find NDMA levels in some metformin products but determined the levels were too low for concern.  “To date,” the FDA wrote, “no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.”

Valisure challenged the FDA’s testing methods in its citizen’s petition, stating, “It is unclear what methodology FDA used to select the limited scope of batches and companies that were tested; though given Valisure’s results, it appears a much broader approach may be necessary.”

Valisure added that it would not sell the affected batches of products on its site, even though it couldn’t get a refund from the manufacturer for those tainted products because they hadn’t been recalled.

10 Comments

  1. Gravatar for kristina Mullen
    kristina Mullen

    According to the FDA in the US five companies who were notified of the agency’s testing results and who are recalling their extended-release (ER) product, and specific labeling and lots recalled, are:

    Apotex – all lots

    Amneal – all lots

    Marksans, branded as Time-Cap – one lot (XP9004)

    Lupin – one lot (G901203)

    Teva, branded as Actavis – 14 lots

    but according to Valisure Ascend Metformin products are contaminated. Who is telling the truth?

    Thank you Kristina

    1. Gravatar for Pamela A King
      Pamela A King

      I just received an FDA recall for Amneal Pharmaceuticals. I use Walmart Pharmacy, who mailed me the recall information. Today has been hard because I have been fighting proactively for my health for years, and these past few years, it has gotten significantly worse.

  2. Gravatar for Joy Allen
    Joy Allen

    I have Metformin Hcl ER 500 mg tablets manufactured by Ascend Labs. Every time I take them I feel sick to my stomach like I’ve eaten some that I shouldn’t have. Wonder if these tablets that I have are on the recall list too. Would like to know if anyone else gets sick immediately after taking them too.

    1. Gravatar for Pamela A King
      Pamela A King

      I have had ongoing, extreme stomach/bowel problems as well as very bad rashes.

    2. Gravatar for Miesha Carter
      Miesha Carter

      I also have been experiencing stomach/bowel issues since starting Metformin in April 2020.

    3. Gravatar for Gina Swayne
      Gina Swayne

      About 1 1/2 years ago, I felt like I was dying. I went to my family Doctor and asked her to put me in the hospital to run test to find out what was wrong. I suspected a medication or combination of medications I was taking was causing me to have frequent near fainting spells, called grey outs I think, having trouble breathing & irregular heartbeat. I was scared to shower, couldn't stand up long enough to cook most of the time, off balance, could barely walk, shouldn't have been driving and was losing weight rapidly. All my doctor did was draw blood, told me to come back in 2 weeks. She said everything was fine except B12 was low, but that's not all that was wrong. I was taking Ascend Labs Metformin Hcl Er Tabs 500 mg 2x/day. I told my Doctor I was not going to take most of my meds as I had to do something to save my own life. I started taking B12 and other supplements and began to feel better. Because my A1C went up a physicians assistant suggested I start taking Metformin again in April this year. Now I'm concerned & confused as to if I should continue taking it. My mail order pharmacy alerted me to the recall, I called my Doctor and she said I should take different medication. She chose a injectable type, but its risk is cancer and its extremely expensive for me even with the manufacturer disc card. Can't they make a medication without risk of another disease or death?

  3. Gravatar for Tammy
    Tammy

    Just took my bottle to the Pharmacy and found out the Metformin I was taking is on the recall list.

    Now I get to sit and think about if I will get Cancer or if I have Cancer.

    Not a good feeling and pretty scary.

  4. Gravatar for Leonard Hall
    Leonard Hall

    Taking for 17 years

  5. Gravatar for charles
    charles

    i been taking this med for ten yrs it caused rnail failureit put me in the hospital for aweek

  6. Gravatar for Sathyanarayana Venkatasubba Sastry
    Sathyanarayana Venkatasubba Sastry

    I came to know about this recall, I still got same medication provided by my pharmacy. What can I do?

Comments are closed.