Recalls & safety alerts

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Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP – Expanded

Recall date
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Brand

Torrent Pharmaceuticals
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Lot code/Notes

NDC 13668-409-10, Losartan Potassium Tablets, USP 50mg, 1000 count, Batch 4DU2E009, Exp. Date: 12/31/2020

NDC 13668-115-90, Losartan Potassium Tablets, USP 100mg, 90 count, Batch 4DU3E009, Exp. Date: 12/31/2020

NDC 13668-115-10, Losartan Potassium Tablets, USP 100mg, 1000 count, Batch 4DU3D018, Exp. Date: 02/28/2021

NDC 13668-116-90, Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count, Batch BEF7D051, Exp. Date: 1/30/2020

NDC 13668-118-90, Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count, Batch 4P04D007, Exp. date: 07/31/2020

See all recalled angiotensin II receptor blockers (ARBs) including Valsartan, Losartan and Irbesartan: https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and
Reason
Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA)