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Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, p Supply Disruption — Sunstar Americas, Inc. (Moder

Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, p Supply Disruption — Sunstar Americas, Inc. (Moder is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, p; Manufacturer: Sunst

Drug nameParoex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, p
ManufacturerSunstar Americas, Inc.
Recall/Disruption reasoncGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamin
Risk classificationModerate Risk — Temporary Health Consequence
StatusOngoing
Record typeEnforcement/Recall
Recall numberD-0222-2021
Initiation date20201228
Quantity affecteda) 1,021,914 bottles; b) 255,552 bottles
Dosage formDrugs

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