# FDA recall D-0222-2021

> **Sunstar Americas, Inc.** · Class II · drug recall initiated 2020-12-28.

## 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

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0222-2021
- **Recalling firm:** Sunstar Americas, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2020-12-28
- **Report date:** 2021-01-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0222-2021

## Citation

> AI Analytics. FDA recall D-0222-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0222-2021. Source: US FDA. Licensed CC0.

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