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Sun Pharmaceutical Industries Recalls NDMA-Tainted Metformin

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Sun Pharmaceutical Industries, Inc. voluntarily recalled one lot of Riomet ER (metformin hydrochloride) on Wednesday due to contamination with N-Nitrosodimethylamine (NDMA).

Levels of NDMA in the product were found to be above the U.S. Food and Drug Administration’s (FDA) acceptable daily intake limit. The lot recalled was of a 500 mg per 5 mL extended-release oral suspension.

NDMA is classified as a probable carcinogen by the Environmental Protection Agency and the International Agency for Research on Cancer. The World Health Organization said there exists “conclusive evidence that NDMA is a potent carcinogen.”

Riomet is packaged in a 16 oz. Round bottle. Every carton contains a bottle of drug pellets, a bottle of diluent and a dosing cup. The lot number affected is AB06381. The NDC number affected is 10631-019-17. The lot’s expiration date is 10/2021. 747 cartons have been recalled. The drug was distributed across the country to wholesalers.

Sun Pharma is notifying its customers and distributors through a third-party recall coordinator, Inmar Inc., via FedEx standard overnight shipping. The company is arranging for the return of all recalled metformin.

Patients taking Riomet ER are advised to keep taking their medication and contact a healthcare provider for advice about alternative treatment. It might be dangerous for patients to stop taking metformin without talking with healthcare professionals first, according to the FDA.

The recall is just one many in a long string of metformin recalls, all due to contamination with NDMA. The sequence of events began when Singapore’s Health Sciences Authority announced in December 2019 that they found NDMA in three medications containing metformin at levels above the internationally accepted limit.

The announcement prompted testing lab Valisure to test 38 batches of metformin for NDMA contamination. Valisure found 16 of the batches contained NDMA at levels above the FDA’s acceptable limit, many of the batches containing over 10 times that limit. Valisure subsequently sent a citizen petition to the FDA, urging the agency to recall the drug.

A complete list of metformin products recalled in the United States can be found here.

Manufacturers of metformin are now facing multiple lawsuits over their drugs being contaminated with NDMA. These lawsuits claim that metformin manufacturers failed to warn consumers about the cancer risk associated with their drugs despite the fact they knew or should have known of the risk. The lawsuits also claim that the contaminated metformin drugs contain a manufacturing defect.


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