Paroex — Class II drug recall D-0222-2021
Ongoing recall by Sunstar Americas, Inc., reported 2021-01-20, distributed nationwide. cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC
| Recall number | D-0222-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunstar Americas, Inc., Schaumburg, IL, United States |
| Recall initiated | 2020-12-28 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, cgmp |
| Pathogens | burkholderia |
| NDC | 52376-0021-02 |
Product
Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
Reason for recall
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0222-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.