Certain Metformin diabetes drugs recalled due to the presence of NDMA

Starting date:
February 5, 2020
Posting date:
February 26, 2020
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-72287

Last updated:

Summary

  • Product: Certain brands of diabetes drugs containing metformin.
  • Issue: Products contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA), above or close to the acceptable limit.
  • What to do: You should not stop taking your metformin drug without first discussing options with your health care provider. Talk to your health care provider to discuss treatment options if you are taking or have taken a recalled product and are concerned about your health.

UPDATE: February 26, 2020

Ranbaxy Pharmaceuticals Canada Inc. is recalling six lots of its prescription RAN-Metformin drug from the Canadian market. Company testing identified two lots (#AJY8006A and #AJY8007A) with levels of NDMA above what is considered acceptable if the drug were to be taken over a lifetime. The company is recalling an additional four lots (#AJY8005A, #AJY8005B, #AJY8008A and #AJZ8005A) as a precautionary measure because they contain NDMA close to the acceptable limit. Please refer to the Affected products table below for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table below and inform Canadians.

Original Information Update: February 5, 2020 - Apotex Inc. recalls certain lots of the diabetes medication APO-Metformin ER (extended release) 500 mg tablets

Issue

Apotex Inc. recalls certain lots of the diabetes medication APO-Metformin ER (extended release) 500 mg tablets

You should not stop taking your medication without first discussing treatment options with your health care provider. The risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of nitrosamines found in the recalled Apotex metformin products.

Apotex Inc. is recalling eight lots of its 500 mg extended release metformin tablets (“APO-Metformin ER”) because they contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) above the acceptable limit. Apotex Inc. has tested all lots of its 500 mg extended release tablets; only the affected lots are being recalled (see table below). There are also alternative metformin products on the Canadian market manufactured by other companies.

Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.

Individuals taking metformin, including a recalled product, should not stop taking it unless they have spoken to their health care provider as the risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products.

NDMA is classified as a probable human carcinogen. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. NDMA is not expected to cause harm when ingested at low levels. A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

In December 2019, Health Canada communicated that it is assessing the issue of NDMA in metformin products, after some metformin products available outside Canada were detected to contain NDMA above the acceptable limit. The Department asked companies to test their metformin products and is conducting testing in its own laboratories. Health Canada is also working closely with international regulatory partners, including the U.S. Food and Drug Administration and the European Medicines Agency, to inform its assessment. Health Canada continues to assess this issue, and will update the table below and inform Canadians should any additional recalls be necessary.

Health Canada has been working to address the issue of NDMA and other nitrosamine impurities found in certain medications since the summer of 2018. Health Canada continues to work closely with international regulatory partners to address the issue. The Department will take action if a new risk to Canadians is identified, and will continue to inform the public of new safety information.

Who is affected

Patients who are taking an affected metformin drug.

What consumers should do

You should not stop taking your metformin drug without first discussing options with your health care provider. The risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products. Stopping metformin medication could lead to uncontrolled diabetes, which can cause serious health problems such as:

  • High blood sugars. Symptoms of high blood sugars include increased urination, thirst, excessive hunger, fatigue, blurred vision, drowsiness, irritability, unintended weight loss and dizziness. Very high blood sugars can lead to effects such as vomiting, diarrhea, dehydration, confusion, agitation and coma.
  • Longer-term health impacts. These include heart disease, nerve problems, kidney damage, blindness and amputations.
  • Talk to your health care provider to discuss treatment options if you are taking a recalled product or if you have taken a recalled product and are concerned about your health.
    • Ask your pharmacist if you are unsure whether you are taking a recalled product.
  • Report any health product adverse events or complaints to Health Canada.
  • Contact the company directly if you have questions about a recall:
    • Apotex Inc. via Stericycle ULC by calling toll-free at 1-855-853-9461.
    • Ranbaxy Pharmaceuticals Canada Inc. by calling toll-free at 1-866-840-1340, or by e-mail at canadacustomerservice@sunpharma.com

Affected products

The following is a list of metformin drugs being recalled in Canada at this time:

Company Product Name/Active Pharmaceutical Ingredient (API) DIN Strength Lot Expiry
Apotex Inc. APO-Metformin ER (Metformin Hydrochloride Extended-Release Tablets) 02305062 500 mg NV3242 04/2020
NV3244 04/2020
NV3245 04/2020
NV3243 04/2020
NV3247 04/2020
NV3248 04/2020
PX5334 01/2021
PX5335 01/2021

Ranbaxy Pharmaceuticals Canada Inc.

RAN-Metformin

02269031

500 mg

AJY8006A

05/2020

500 mg

AJY8007A

05/2020

500 mg

AJY8005A

05/2020

500 mg

AJY8005B

05/2020

500 mg

AJY8008A

05/2020

850 mg

AJZ8005A

05/2020

Related links

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