Aurobindo Pharma Limited has further advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers to return Irbesartan drug product and finished Irbesartan tablets that has been identified by Aurobindo Pharma Limited.Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Find out which specific blood pressure medications are affected by the recallSearch the full list of recalled angiotensin II receptor blockers (ARB) below by company, medicine, National Drug Code (NDC), lot number, or expiration date If a manufacturer detects new or higher levels of impurities, they should fully evaluate the impurities and take action to ensure the product is safe for patients.RemedyRepack, a repackager of Torrent’s valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets, has also recalled.FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall.Additionally, FDA is releasing a gas chromatography-mass spectrometry FDA recently learned Torrent used affected valsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. The irbesartan recall is the latest involving a large class of blood pressure drugs called angiotensin II receptor blockers, which work by blocking the effects of a … 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.
Untreated diabetic nephropathy (kidney disease) leads to worsening renal (kidney) disease.Manufacturers should contact FDA’s Drug Shortages Staff when their testing of losartan shows levels of NMBA that exceed the interim acceptable intake limit of 0.96 ppm. For the latest FDA MedWatch alerts, 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. In the past year, the agency has conducted multiple unannounced, for-cause inspections to evaluate the practices at various API manufacturers and to verify appropriate corrective actions to address the risk of nitrosamine contamination. Two of these companies, A-S Medication and RemedyRepack, may also distribute valsartan products not affected by the recall.
Instructions for returning recalled products are provided in the Recall Notice Letter and Recall Response Form. These lots were distributed nationwide in the USA to GSMS’ direct accounts.Complete the Recall Inventory Response Form and return to Golden State Medical Supply Incorporated email: If you are taking Irbesartan, please examine your tablets and look for the specific markings to determine if you’re product is affected by this recall. The agency reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option.
* The acceptable intake is a daily exposure to a compound such as NDMA or NDEA that results in a 1:100,000 cancer For comparison with the levels of NDMA found in some common foods, please see our Aug. 20, 2018, The agency also updated the list of valsartan products under recall and the list of valsartan products not under recall.Teva is recalling all lots of amlodipine and valsartan combination tablets and amlodipine, valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to the presence of N-Nitrosodiethylamine (NDEA). 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. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities.
An official website of the United States government: