The agency is confirming this information and will provide an update once it is available.The following additional repackagers are recalling or are expected to recall valsartan-containing products. The warning letter outlines several current good manufacturing practice (CGMP) deviations at this Mylan facility, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils. AurobindoPharma, which recalled 80 lots of Valsartan medicines that had too much NDEA in January, added another 38 lots of Valsartan and Valsartan with Amlodipine tablets Friday. The action taken by Aurobindo is the latest recall related to valsartan. Failure to correct these deviations may result in further action by the agency. The FDA continues to work with API and drug manufacturers to ensure their products are not at risk for NDMA or NDEA formation. It also is important to know not all ARBs contain NDEA or NDMA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.ScieGen’s recall affects about 1 percent of the irbesartan drug products in the U.S. market.Additionally, Aurobindo, which manufactures the active pharmaceutical ingredient (API) for ScieGen’s irbesartan products, is FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. To aid industry and regulatory agencies, FDA has developed and published methods to detect NDMA and NDEA impurities – the gas chromatography/mass spectrometry Not all ARB products contain NDMA or NDEA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition. The European Directorate for the Quality of Medicines (EDQM) has also published FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities. FDA has product recall information from three additional repackagers of valsartan-containing products made by Teva Pharmaceuticals and Prinston Pharmaceuticals Inc. – labeled as A-S Medication Solutions LLC, AvKARE and RemedyRepack – and the agency has added them to the recalled products list. We will post the method when it is available. The presence of the potentially cancer-causing NDMA was unexpected, and the agency believes the NDMA is related to changes in the way the active substance was manufactured. FDA is working to gather product recall information from these companies and has removed them from the list of products that are not impacted by this recall:It is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. Teva has recalled other valsartan-containing products in recent months due to the presence of N-Nitrosodimethylamine (NDMA). Patients who prescribed Amlodipine Valsartan Tablets USP and Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.Amlodipine Valsartan Tablets USP and Valsartan Tablets USP were distributed nationwide to AurobindoPharma USA, Inc. and Aceteris Health LLC wholesale, distributor, repackager and retail customers. This method should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission.FDA is also working on a GC/MS direct injection method for detection of NDMA and NDEA. The agency reminds manufacturers they are responsible for developing and using suitable methods to detect impurities, including when they make changes to their manufacturing processes.