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Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By Supply Disruption — Direct Rx (Moderate Risk — Te

Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By Supply Disruption — Direct Rx (Moderate Risk — Te is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By; Manufacturer: Direc

Drug nameLosartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By
ManufacturerDirect Rx
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
StatusTerminated
Record typeEnforcement/Recall
Recall numberD-0018-2021
Initiation date20190430
Quantity affected33 bottles
Dosage formDrugs

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