MHRA has recalled 3 batches of Losartan tablets due to contamination with the nitrosamine N-nitroso-N-methylamino butyric acid. 12/31/2019: 13668-116-30: Losartan Potassium/ Hydrochlorothiazide Tablets, USP … 2019-04-26 16:03:00. According to Teva, this recall was initiated by detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in 6 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the FDA’s interim acceptable exposure limit of 9.82 ppm.Teva Recalls 35 Lots of Bulk Losartan Potassium TabletsAccording to Teva, this recall was initiated by detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in 6 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the FDA’s interim acceptable exposure limit./resource-centers/cardiovascular-health/teva-recalls-35-lots-of-bulk-losartan-potassium-tablets2 Clarke Drive Suite 100 Cranbury, NJ 08512 P:609-716-7777 F:609-716-9038

... Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply [news release]. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment, it noted.To date, Teva said it has not received any reports of adverse events related to the lots being recalled.It said no other Teva losartan potassium finished drug products have been identified, in the United States, containing API above the interim specification levels set for NMBA.Teva Pharmaeceuticals USA labeled as Major Pharmaceuticals was one of the first companies in July to issue a recall on an API due to the presence of a nitrosamine impurity.It recalled valsartan 80 and 160 milligram products after NDMA was found in the active pharmaceutical ingredient manufactured by China-based Zhejiang Huahai Pharmaceuticals.The presence of NDMA was described as unexpected at the time, and the FDA said it believed the NDMA was related to changes in the way the active substance was manufactured. The FDA has announced two added recalls of blood pressure medication tainted with a cancer-causing impurity. Macleods also recalled one lot of the losartan combination drug in February for the same reason. This is the fifth time in 2019 that Torrent Pharmaceuticals has expanded its voluntary recall of losartan. The FDA is alerting patients and health care professionals to a voluntary recall of 44 lots of losartan potassium tablets manufactured by Teva Pharmaceuticals USA and sold under the label Golden State Medical Supply.NMBA, a chemical compound in the nitrosamines class, is considered a potential human carcinogen at certain exposure levels long-term.It is the most recent nitrosamine impurity that the FDA has set limits for in ongoing recalls involving the class of blood pressure drugs known as angiotensin II receptor blockers (ARBs) since July because of the detection of unacceptable levels of nitrosamines in their active pharmaceutical ingredient such as losartan, valsartan or irbesartan.Teva said NMBA was found in six lots of valsartan above the FDA’s interim acceptable exposure limit of 9.82 ppm. According to Teva, this recall was initiated by detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in 6 lots of active pharmaceutical ingredient (API) manufactured by Hetero … The news and stories that matter, delivered weekday mornings.

Trending Now. The recall was issued due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. For questions about returning the product, contact Qualanex via email at Here are the doses, lot numbers and expiration dates of the recalled medicine:© 2020 USA TODAY, a division of Gannett Satellite Information Network, LLC. Next 11 results. The recalled losartan and potassium/hydrochlorothiazide combination tablets contained small amounts of N-nitrosodiethylamine, or NDEA, according to a company notice posted to "Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out," the recall notice states.The active drug ingredient was manufactured at Hetero Labs Limited in India, one of the overseas drug factories linked to Health care professionals advise patients to consult with their doctors or pharmacists before discontinuing one of the recalled blood pressure medicines or finding an alternative treatment.Discontinuing a recalled drug could cause more immediate harm than staying on the medication.Consumers with medical questions or to report an adverse event can contact Macleods at 855-926-3384 from 8 a.m. to 5 p.m. EST.

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