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Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bo Supply Disruption — Teva Pharmaceuticals USA (Mod

Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bo Supply Disruption — Teva Pharmaceuticals USA (Mod is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bo; Manufacturer: Teva

Drug nameValsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bo
ManufacturerTeva Pharmaceuticals USA
Recall/Disruption reasonCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Risk classificationModerate Risk — Temporary Health Consequence
StatusOngoing
Record typeEnforcement/Recall
Recall numberD-0988-2018
Initiation date20180716
Quantity affected15,347 90-count bottles, 8,378 1000-count bottles
Dosage formDrugs

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