# FDA recall D-0228-2021

> **Precision Dose Inc.** · Class II · drug recall initiated 2021-01-01.

## Product

Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.

## Reason for recall

cGMP deviations: The firm was notified of the manufacturer's expanded recall.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0228-2021
- **Recalling firm:** Precision Dose Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-01-01
- **Report date:** 2021-01-20
- **Termination date:** 2024-07-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2021

## Citation

> AI Analytics. FDA recall D-0228-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0228-2021. Source: US FDA. Licensed CC0.

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