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Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count Supply Disruption — Torrent Pharma Inc. (Moderate

Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count Supply Disruption — Torrent Pharma Inc. (Moderate is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count; Manufacturer: Torrent

Drug nameLosartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count
ManufacturerTorrent Pharma Inc.
Recall/Disruption reasonCGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product a
Risk classificationModerate Risk — Temporary Health Consequence
StatusOngoing
Record typeEnforcement/Recall
Recall numberD-1118-2019
Initiation date20190228
Quantity affected172,296 bottles
Dosage formDrugs

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