In addition to metformin and the blood-pressure drugs, the FDA last month asked for a recall of all versions of Zantac, which is also sold …

The recall includes a range of NDC numbers, lot numbers, and expiration dates.
Issue

Look for … The U.S. Food and Drug Administration (FDA) said on Thursday it has recommended five pharmaceutical firms to voluntarily recall their diabetes drug metformin …

FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).The agency is also asking all companies manufacturing ER metformin to evaluate the risk of their product containing NDMA above the acceptable intake limit and to test at-risk product before each batch is released onto the U.S. market.

This image made available by the U.S. Food and Drug Administration on Thursday, May 28, 2020 shows a label for the drug metformin. U.S. health regulators are telling five drugmakers to recall versions of the widely used diabetes medication after testing revealed elevated levels of a contaminant linked to cancer in several lots.

The lot was manufactured in-house at Sun's Halol facility and the recall is ongoing. This image made available by the U.S. Food and Drug Administration on Thursday, May 28, 2020 shows a label for the drug metformin. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional.

Diabetes “coaching” services are available in-person and remotely via phone and the internet for children and adults.

It also recommends that clinicians continue to prescribe metformin when clinically appropriate.

Integrated Diabetes Services is the worldwide leader in one-on-one consulting for people who use insulin.

It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.FDA plans to post the methods used in laboratory testing of metformin in the near future. Original Information Update: February 5, 2020 - Apotex Inc. recalls certain lots of the diabetes medication APO-Metformin ER (extended release) 500 mg tablets . The World Health Organization has compiled data that shows high levels of exposure over time have been linked to a higher risk of developing some cancers.

Fearing microbial contamination, Sun Pharmaceutical Industries Ltd. has recalled two batches of its anti-diabetic drug Riomet (Metformin Hydrochloride Oral Solution). The diabetes medication in the 750 mg dosage are light-yellow capsule-shaped tablets with the Andrx logo debossed on them and “577” on one side and “750” on the other side.Consumers are advised to continue taking the recalled medication and to contact their healthcare provider for an alternative drug treatment.

“Out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the U.S.,” the announcement reads. U.S. health regulators are telling five drugmakers to recall versions of the widely used diabetes medication after testing revealed elevated levels of a contaminant linked to cancer in several lots. The FDA said it found no metformin products that exceeded daily intake limits of N-Nitrosodimethylamine (NDMA) so it did not recommend recalling the type 2 oral diabetes drug in the U.S. FDA-published testing method to provide an option for regulators and industry to detect NDMA impuritiesThe links below are to FDA-published testing methods to provide an option for regulators and industry to detect nitrosamine impurities in metformin drug substances and drug products.

The recall for all lots of metformin hydrochloride extended-release tablets 500 mg from Apotex comes after one lot tested by the U.S. Food and Drug Administration had higher NDMA levels than allowed by the FDA.NDMA is an environmental contaminant that's found in water and foods, including meats, dairy products, and vegetables.Metformin hydrochloride extended-release tablets are prescribed to be used along with diet and exercise to improve NDMA contamination triggered numerous recalls of widely-used heart medicines last year.See how one patient learned to manage her weight and diet.WebMD does not provide medical advice, diagnosis or treatment. Overall, FDA observed that in orthogonal tests, the levels of NDMA, when present, were generally lower than reported by the private laboratory.The paper provides additional details of FDA’s investigation and the importance of selection and validation of testing methods.In summary, the agency found the private laboratory method to be inappropriate for quantifying NDMA in metformin drug products due to presumptive overestimation of NDMA caused by the presence of a substance that interfered with the testing results.There are additional companies that manufacturer ER metformin and supply a significant portion of the U.S. market, whose products are not being recalled at this time.Patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. Why all not recalled if it’s not safe to still use?the contamination is specific to certain manufacturers, so there is no need to recall all metformin products at this time.

“Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market.” Metformin Recalled for Possible Cancerous Chemical June 1, 2020 -- A recall of the widely-used diabetes drug metformin was announced by drug …
The recall does not apply to immediate-release metformin products, the most commonly prescribed ones for diabetes, the agency stresses.