Another Metformin Recall Due to Carcinogen Concerns

metformin recall

The U.S. Food and Drug Administration (FDA) has identified yet another metformin recall due to higher-than-acceptable levels of carcinogen N-Nitrosodimethylamine (NDMA).  This marks the sixth drugmaker to recall metformin and pull lots from the market.  Here is our continuing coverage of this medication recall.

Another Metformin Recall Due to Carcinogen Concerns

According to the FDA Company Announcement, Bayshore Pharmaceuticals, LLC is voluntarily recalling one lot each of 500 mg and 750 mg Metformin Hydrochloride Extended-Release Tablets USP.  The metformin was manufactured by Beximo Pharmaceuticals Limited in Dhaka Bangladesh.  It was then sent to Bayshore for distribution in the United States.

The FDA says that both lots contain NDMA levels in excess of their established Acceptable Daily Intake Limit (ADI).  During tests, the FDA found unusually high levels of NDMA in certain samples.  The FDA recommended a recall, which Bayshore then did voluntarily.

Consumers can identify the medication in this metformin recall by the following:

Metformin Hydrochloride Extended-Release Tablets USP, 500 mg

  • 1000-count bottle
  • NDC #76385-128-10
  • Lot #18641
  • Expiration May, 2021

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg

  • 100-count bottle
  • NDC #76385-129-01
  • Lot #18657
  • Expiration May, 2021

Consumers who have these varieties of metformin should contact their healthcare provider.  The FDA says consumers should not stop taking any medication without the guidance and supervision of a doctor.

What are the Risks of NDMA Exposure?

NDMA is a probable human carcinogen, which means that the substance could cause cancer.  The substance occurs naturally in certain foods, dairy products, produce and water.  These amounts are generally low and should not cause problems.

In medications, however, NDMA levels may be concentrated and patients may be exposed to the substance for a long period of time.  That can increase the risks of NDMA exposure and the potential to develop certain cancers.

The World Health Organization (WHO) considers NDMA to be a “potent carcinogen.” In animal studies, ingestion of NDMA increases the risk of certain cancers.  It also can cause serious health effects.  The Environmental Protection Agency (EPA) lists the following possible health risks:

  • Headache
  • Fever
  • Jaundice
  • Abdominal cramps
  • Liver damage
  • Lung damage
  • Tumors of the respiratory tract, kidneys, liver and blood vessels

The tumors that may develop in the respiratory tract, kidneys and liver could be cancerous.  Continued exposure to NDMA could increase the risk of cancer.

Have Questions about the Metformin Recall?

Consumers who have questions about the metformin recall can contact Bayshore Pharmaceuticals by calling 1-877-372-6093.  Consumers who have this product and want to return it can do so by contacting Qualanex, LLC – a product recall processor for Bayshore.  Qualanex will send consumers a return kit and instructions, with instructions for reimbursement.

Consumers who experience an adverse event or quality problem with this metformin can also contact the FDA.  The FDA recommends filing a report through the MedWatch Adverse Event Reporting program.

If you have legal questions about the metformin recall, you can always count on Drug and Device Watch to be here for you.  Our legal professionals can help you understand your rights as a consumer.  Furthermore, we can help you explore your options if you suffer harm due to a defective medical device or medication.  Find out how we can help by calling us at 1-888-458-6825.  You can also request a free legal consultation by filling out our online form.