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Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Supply Disruption — RemedyRepack Inc. (Moderate R

Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Supply Disruption — RemedyRepack Inc. (Moderate R is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625; Manufacturer: Remed

Drug nameValsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625
ManufacturerRemedyRepack Inc.
Recall/Disruption reasonCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Risk classificationModerate Risk — Temporary Health Consequence
StatusTerminated
Record typeEnforcement/Recall
Recall numberD-1021-2018
Initiation date20180717
Quantity affected3 HDPE 90-count bottles (270 tablets)
Dosage formDrugs

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