# FDA recall D-0111-2021

> **Lohxa LLC** · Class I · drug recall initiated 2020-10-28.

## Product

Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15

## Reason for recall

Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

## Distribution

Product was distributed to medical facilities in FL and NY.

## Key facts

- **Recall number:** D-0111-2021
- **Recalling firm:** Lohxa LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-10-28
- **Report date:** 2020-12-09
- **Termination date:** 2022-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Worcester, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0111-2021

## Citation

> AI Analytics. FDA recall D-0111-2021. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/D-0111-2021. Source: US FDA. Licensed CC0.

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