# FDA recall D-0231-2017

> **Sage Products LLC** · Class II · drug recall initiated 2016-07-29.

## Product

2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.

## Reason for recall

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

## Distribution

Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.

## Key facts

- **Recall number:** D-0231-2017
- **Recalling firm:** Sage Products LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-07-29
- **Report date:** 2016-12-28
- **Termination date:** 2019-03-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2017

## Citation

> AI Analytics. FDA recall D-0231-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0231-2017. Source: US FDA. Licensed CC0.

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