Carcinogen NDMA exceeds the standard! Sun Pharmaceuticals of India has recalled Riomet ER, a slow-release agent for metformin.

The commonly used diabetic drug metformin has become one of the most popular drugs on the U.S. market for recalls due to the cancer-causing impurities NDMA.
this week, the FDA also joined the recall of metformin after it found high levels of cancer-causing pollutants in a diabetes drug owned by Sun Pharma in India.
On Wednesday, Sun Pharmaceuticals said it would recall some batches of Riomet ER (slow-release oral suspension of metformin hydrochloride, 500mg/5ml), a slow-release version of the diabetes drug Riomet.
the recall is due to the potential levels of nitroamine impurities N-nitrodiamine (NDMA) that exceed the daily allowable intake (ADI) set by the FDA.
the recalled batch contains 747 bottles of the drug, which will be valid until October 2021, the company said in a press release.
so far, Sun Pharmaceuticals has not received any reports of adverse events related to the recall.
distributors and retailers with recalled RIOMET ER should stop distributing the modified drug and return it to the original purchase channel or follow the instructions in the recall notice.
noted that this is not the first time the series has been recalled.
, according to a drug recall report released by the FDA in November 2017, Riomet voluntarily recalled some Riomet products because of microbial contamination.
the FDA in May asked five drugmakers, including Lupin, to remove their diabetes-related drugs from their shelves because of NDMA's excesses.
July, Lupin Pharmaceuticals withdrew all metformin slow-release products after high levels of NDMA were found in samples.
just days after Granules Pharmaceuticals, based in Virginia, announced a recall of all metformin-relieved products on the market because of the same pollution problem.
August, Bayshore Pharmaceuticals, based in New Jersey, also recalled batches of 500mg and 750mg metformin slow-release products for NDMA.
, the FDA said it would work with the companies to determine whether the recall would lead to a shortage of diabetes drugs in the U.S. market.
The recall also does not apply to rapid-release preparations for metformin, and the FDA said that "there are many more manufacturers of metformin reprieve preparations, which account for a large portion of the U.S. market, and their products have not been recalled."
previously, the high blood pressure drug "shatan" and the heartburn drug Zantac had been recalled worldwide for containing the carcinogen impurities NDMA.
the seventh drugmaker to recall metformin after the FDA found high levels of NDMA in drugs earlier this year.
seven drugmakers, including Apotex, Teva, Amneal and Marksans, all launched voluntary recalls in early June.
source: 1, Sun Pharma Recalls One Lot Of Diabetes Drug RIOMET ER Oral - Quick Facts 2, Sun Pharma latest to recall metformin after carcinogens tests up come positive.