losartan recall list 2020
FDA will also post test results and an assessment of the cancer risk from NDEA when they are available. This recall is due to trace amounts of N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). FDA has updated lists of valsartan products under recall and valsartan products not under recall. HV9471. If you have questions about this recall, Medichem S.A., 1-201- 420-1800 November 2020 Class II Metformin Hydrochloride Extended Release Tablets 04948362401 CGMP Deviations If you have questions about this recall, Medichem S.A., 631-753- 9090; ext. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the 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. 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. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per international Agency for Research on Cancer (IARC) classification. Update [11/21/2018] FDA is alerting patients and health care professionals to Mylan Pharmaceuticals’ voluntary recall of 15 lots of valsartan-containing products due to the presence of N-Nitrosodiethylamine (NDEA). If you are taking a valsartan product, be sure to check to back as the lists may change. There are currently three voluntary recalls related to the NDMA impurity detected in the valsartan API: What health care professionals should know: Consumers and health care professionals should report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem: September 19, 2019 -- Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium / hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. FDA’s action follows a recent inspection at ZHP’s facility. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. 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. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. We have known that certain drug manufacturing processes pose a risk for forming genotoxic impurities, and this is an issue the FDA and other regulators have been working on for a number of years – well before the nitrosamine impurities were discovered in ARBs last summer. Patient safety and product quality are critical to Teva. Update [2/28/2019] FDA is posting the updated table of interim acceptable intake limits for nitrosamine impurities to reflect N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) limits, which are the same as those for NDMA.The agency will use the interim limits below to recommend manufacturers conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in finished drug product. FDA believes the benefits of ARBs continue to outweigh their potential risks. In December 2018, Torrent Pharmaceuticals began a voluntary recall of losartan due to the presence of small traces of known carcinogens. Torrent further expands its voluntary recall of losartan. We know that ARBs can be produced without nitrosamine impurities, and we are working with manufacturers to reach that point. 18 Dez, 2020. The agency also updated the list of losartan products under recall. 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. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Products Affected - Description. Torrent is arranging for return of all recalled products to Qualanex. Some manufacturers are recalling some medications containing amlodipine in combination with valsartan or losartan, and some medications containing hydrochlorothiazide HCTZ in combination with valsartan or losartan are also being recalled. Date 06/2020. Update [2/25/2019] FDA is alerting patients and health care professionals to a voluntary recall of one lot of losartan potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets manufactured by Macleods Pharmaceuticals.
A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Check out what's clicking on Foxnews.comTorrent Pharmaceuticals Limited said its Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, are affected by the recall.The ingredient detected was identified as N-Methylnitrosobutyric acid (NMBA), a known animal and potential human carcinogen. The agency is using this method to test potential NDMA-containing APIs and drug products. FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall. Update [11/13/2019] Today, the U.S. Food and Drug Administration posted a warning letter to Mylan Pharmaceuticals, Inc. in Chodavaram Village, Vizianagaram, Andhra Pradesh, India. Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall. FDA has posted a list of currently available ARBs and the status of our assessment of those medications. 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. We will also continue to provide timely updates about any future issues associated with this ongoing incident that may impact public health. To date, ScieGen is the only manufacturer of irbesartan drug products found to contain NDEA. We are currently aware of NDMA and NDEA in certain valsartan, irbesartan and losartan-containing products, and those products and some active pharmaceutical ingredients (API) used to manufacture them have been recalled from the U.S. market. Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Teva has recalled other valsartan-containing products in recent months due to the presence of N-Nitrosodimethylamine (NDMA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA. 160 November 2020 Class II Metformin Hydrochloride - Extended-Release Tablets 04948362309 04948362301 04948362350 04948362310 … Samples can also be affected and part of the recall. Update [8/22/2018] Torrent Pharmaceuticals Limited is expanding its voluntary recall to all lots of unexpired valsartan-containing drug products due to the detection of NDMA in the active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. Losartan Potassium was distributed by pharmacies nationwide. The bulk lots were sold exclusively to Golden State Medical Supply, Inc. of Camarillo, California. Any general questions regarding the return of this product should be directed to Qualanex at 1- 888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time). RemedyRepack, a repackager of Torrent’s valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets, has also recalled. If you want the hottest information right now, check out our homepages where we put all our newest articles. This recall is being conducted with the knowledge of the U.S. Food and Drug administration. This method can be used alone or in combination with the combined gas chromatography-mass spectrometry (GC/MS) headspace method the agency recently posted. The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). Untreated heart failure increases the risk of hospitalization and death. The recall covers 25 mg, 50 mg and 100 mg dosages. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products. 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. Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals. These guidances and others developed through ICH are revised as new impurities and risks are identified and have helped prevent unacceptable impurities in drugs. IMPORTANT: Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. We understand that this medicine is … The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. 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. Which ARB medications are being recalled? NDMA has been found to increase the occurrence of cancer in animal studies. Losartan potassium tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Manufacturers only estimate the number of products still in the distribution chain that are subject to recall, but not the number of impacted patients. Lupin and Sandoz did not provide … June 26, 2019 -- Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots of 50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Camber, Avet, Teva, and Torrent were affected by the recall. 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.. Toxicol Res, 2015. If we detect a problem, we will take appropriate action. If you have medication samples from these companies, quarantine the products, and do not provide them to patients. The FDA investigation is still ongoing. For the latest FDA MedWatch alerts, go here. FDA reminds manufacturers that it is their responsibility to develop and use suitable methods to detect impurities, including when they make changes to their manufacturing processes. The investigation into valsartan-containing products is ongoing, and the following list may change.
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