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 name | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, p |
|---|---|
| Manufacturer | Sunstar Americas, Inc. |
| Recall/Disruption reason | cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamin |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0222-2021 |
| Initiation date | 20201228 |
| Quantity affected | a) 1,021,914 bottles; b) 255,552 bottles |
| Dosage form | Drugs |
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