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  1. From FDA https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm “Torrent further expands its voluntary recall of losartan Update [1/23/2019] Torrent Pharmaceuticals is further expanding its voluntary recall to include six additional lots of losartan potassium and hydrochlorothiazide combination tablets, for a total of 16 lots of losartan-containing medicines. This recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing medication containing NDEA above the interim acceptable intake limits of 0.27 parts per million (ppm). The agency also updated the list of losartan medications under recall. Irbesartan distributed by Solco Healthcare voluntarily recalled Update [1/18/2019] FDA is alerting patients and health care professionals to a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare LLC, a Prinston Pharmaceutical Inc. subsidiary. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the irbesartan active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals (ZHP). Solco is only recalling lots of irbesartan-containing medication where NDEA has been detected above the interim limit of 0.088 parts per million. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin receptor II blockers (ARBs). The agency also updated the list of irbesartan products under recall. FDA alerts patients and health care professionals to Aurobindo’s recall of valsartan medication due to NDEA Update [1/2/2019] FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself. Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million. The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels. FDA also updated the list of valsartan products under recall and the list of valsartan products not under recall. FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. Some ARBs contain no NDMA or NDEA.” quick links: “The agency has updated lists for all three kinds of drugs affected by the recalls. For valsartan-containing products currently recalled, click here. For irbesartan-containing products currently recalled, click here. For losartan-containing products currently recalled, click here. ” ETA: Recall expanded Feb 28th, 2019 https://www.fda.gov/Safety/Recalls/ucm632395.htm?utm_campaign=Camber Pharmaceuticals%2C Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets “Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted 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, Unit – I (API manufacturer). NMBA is a potential human carcinogen. To date, Camber has not received any reports of adverse events related to this recall. Losartan Potassium, USP, is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10. The affected Losartan includes 87 lot numbers which are listed below” ETA: Recall expanded March 1st, 2019 https://www.fda.gov/Safety/Recalls/ucm632442.htm “AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.” https://www.fda.gov/Safety/Recalls/ucm632442.htm ETA: Recall expanded March 1st “Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, 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. The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.” https://www.fda.gov/Safety/Recalls/ucm632509.htm ETA: Recall March 7th https://www.fda.gov/Safety/Recalls/ucm632924.htm “American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity Product Description AHP Lot No. Expiration Date Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters Carton NDC#: 60687-139-01 (Individual Dose NDC: 60687-139-11) 179791 3/31/2020 American Health Packaging is notifying its distributors by recall letter sent March 6th, 2019 and to immediately discontinue distribution of the specific lots being recalled and to notify their sub- accounts. American Health Packaging is arranging for return of all recalled products to GENCO Pharmaceutical Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact any patients who may have received the recall lots and have them call (877) 475-5864 to receive a return packet. Consumers should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.” ETA: Expanded 15th March “The identifying NDC number associated with Legacy’s product is as follows: Losartan Potassium, USP, 50mg NDC 68645-494-54 The affected Losartan Potassium includes 3 repackaged lots numbers which are listed below: LEGACY NDC# Name and Strength Count Legacy Lot # Expiry 68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180190 10/2020 68645-494-54 Losartan Potassium Tablets USP 50 mg 30 180191 10/2020 68645-494-54 Losartan Potassium Tablets USP 50 mg 30 181597 02/2021 The product can be identified by checking the product name and repackaged lot number on the bottle containing these products.” https://www.fda.gov/Safety/Recalls/ucm633671.htm ETA: Recall issued March 25th From FDA https://www.fda.gov/Safety/Recalls/ucm633664.htm “Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles. The identifying NDC numbers associated with Legacy’s product are as follows: Losartan Potassium, USP, 25mg NDC 68645-577-54 Losartan Potassium, USP, 50mg NDC 68645-578-54 Losartan Potassium, USP, 100mg NDC 68645-579-54 The affected Losartan Potassium includes 40 repackaged lots numbers which are listed below” https://www.fda.gov/Safety/Recalls/ucm633664.htm “If you have any medical questions regarding this recall, please contact Camber Pharmaceuticals, Inc. at 1-866-495-1995 (8:00 am – 4:30 pm Eastern Time). Consumers with questions regarding this recall can contact your dispensing pharmacy during normal business hours. 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.” ETA: Recall issued April 18th From FDA https://www.fda.gov/Safety/Recalls/ucm636296.htm (affected lots detailed info in link) “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 found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP”
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