JAMP Pharma Corporation is voluntarily recalling all 26 lots of its prescription Metformin drug from the Canadian market (Metformin DIN 02380196 [500mg] and Metformin DIN 02380218 [850mg]) as a precautionary measure.
This paper assesses the cause for the discrepancy between the NDMA values FDA found in its testing of metformin drug products and the values a private laboratory reported.The private laboratory reported levels of NDMA above the acceptable intake limit in 16 of the 38 metformin products they tested. For more information about NDMA, visit FDA’s FDA encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s

It may be more dangerous to stop taking Metformin without the advice of a healthcare professional.Questions and adverse effects from the medication can be directed to Teva Medical Information at 1-888-838-2872 (Option 3, then Option 4), from Monday through Friday from 9 a.m. to 6 p.m.

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. 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.

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The drug is designed to improve blood sugar levels in adults with Type 2 diabetes mellitus. 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. ET or by email at Shares of Teva stock were up 0.63% as of market close on Friday. 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.


FDA is also collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.FDA will continue to monitor NDMA in metformin, along with other drugs products, and will provide timely updates of new developments, including product recalls.

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. Managing diabetes doesn’t mean you need to sacrifice enjoying foods you crave. Update [7/13/2020] FDA is alerting patients and health care professionals to several voluntary recalls of extended release (ER) metformin by the companies listed below. If testing shows NDMA above the acceptable intake limit, the companies must inform the agency and should not release the batch to the U.S. market.Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.