# FDA recall D-1089-2017

> **Akorn Inc** · Class III · drug recall initiated 2017-07-12.

## Product

Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse.  Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012

## Reason for recall

Crystallization with subpotent out of  specification assay results for chlorhexidine.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1089-2017
- **Recalling firm:** Akorn Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-07-12
- **Report date:** 2017-08-23
- **Termination date:** 2018-06-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1089-2017

## Citation

> AI Analytics. FDA recall D-1089-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1089-2017. Source: US FDA. Licensed CC0.

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