The affected lots are being recalled due to an unexpected impurity in the manufacturers’ active pharmaceutical ingredient (API). Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Learn more about the NDC. When we inspected Lantech in March 2019, we determined that solvent recovered by the company contained N-Nitrosodiethylamine (NDEA) and that Lantech had insufficiently assessed the risks associated with their processes and did not adequately investigate the impurities. FDA is working with industry and international regulators to ensure products entering the market do not contain these impurities, but we are tolerating the impurities below the level established in the table for a short period of time to avoid a possible shortage of ARBs. Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side. The recall covers 25 mg, 50 mg and 100 mg dosages. Update [12/6/2018] Mylan Pharmaceuticals is expanding its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by Mylan Laboratories Limited. Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled under the Golden State Medical Supply label should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. 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. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. The lots were sold exclusively to Golden State Medical Supply of Camarillo, California. To put this in context, currently one out of every three people in the US will experience cancer in their lifetime. Report any unexpected side effects with ARB-containing medicines, to FDA’s MedWatch program to help the agency better understand the scope of the problem: Return it to your pharmacist when you get your new medication. Not all ARBs contain NDEA or N-Nitrosodimethylamine (NDMA), a probable human carcinogen previously found in certain recalled valsartan products, 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. Consumers with medical questions regarding this recall or to report an adverse event can contact Macleods Pharmaceuticals Limited at 855-926-3384 (8:00 am - 5:00 pm EST). Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax. Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at: Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Update [9/24/2018] FDA has updated the list of valsartan products not under recall with five Teva products that were not previously on either list. The warning letter is another result of the agency’s ongoing investigation. 1, Rm. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. As always, Teva and Golden State Medical Supply will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). The agency also updated the list of recalled angiotensin II receptor blockers (ARBs) . This … The combined headspace method and the combined direct injection method can detect and quantify NDMA and NDEA simultaneously in ARB API and finished drug products. It will also be printed on the back of a blister pack. Recalls . Contaminated losartan, however, may pose serious health risks. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall to incorporate additional repackagers of Camber’s valsartan products and Torrent’s recall. Before releasing Losartan Recall Lot Numbers List, we have done researches, studied market research and reviewed customer feedback so the information we provide is the latest at that moment. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. The FDA investigation is still ongoing. The FDA is aware many patients rely on ARB medicines, and we are concerned about the presence of nitrosamine impurities in these drugs. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. We are testing samples of other drugs with similar manufacturing processes. Torrent is arranging for return of all recalled products to Qualanex. Like the previously posted methods, 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. Jun 2, 2011. 160 November 2020 Class II Metformin Hydrochloride - Extended-Release Tablets 04948362309 04948362301 04948362350 04948362310 … A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. FDA’s action follows a recent inspection at ZHP’s facility. Camber Pharmaceuticals, Inc. has recalled 87 lots of Losartan Tablets USP. En español | Torrent Pharmaceuticals announced that it has expanded its voluntary recall of blood pressure medications after testing revealed trace amounts of a known probable human carcinogen.. 2020 Election Business Markets ... said Thursday that Torrent Pharmaceuticals has added eight additional lots of losartan potassium tablets to its recall list. Failure to correct these violations may result in further action by the agency. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Losartan Recall FAQs Is Losartan Safe? Torrent manufactures losartan potassium tablets and has been one subject of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers (ARBs) such as valsartan, losartan and irbesartan. FDA recommends health care professionals and patients carefully check these lists. Update [7/27/2018] FDA is updating health care professionals and patients after discovering that several additional companies that repackage drug products are also recalling valsartan-containing products. Legacy Pharmaceutical Packaging LLC is notifying its distributors and customers in writing and is arranging/assisting for return of all recalled products to (a) For Distribution Center Level, please return the products to Legacy Pharmaceutical Packaging LLC; (b) For Retail Level, please return the products to Genco; or (c) For Consumer Level, please return the products to the dispensing pharmacy, whichever is applicable. … Two of these companies, A-S Medication and RemedyRepack, may also distribute valsartan products not affected by the recall. FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. Our ongoing effort has determined that these impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents. Consumers with questions regarding this recall can contact Vivimed C/o Inmar at  1-877-861-3811 Monday – Friday, 9am – 5pm EST. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Update [12/20/2018] FDA is alerting patients and health care professionals to Torrent Pharmaceuticals’ voluntary recall of two lots of losartan potassium 100 mg tablets due to N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. FDA suggests health care professionals check the lists regularly for updates. Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

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