# FDA recall D-1088-2017

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

## Product

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.

## Reason for recall

Crystallization with subpotent out of  specification assay results for chlorhexidine.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1088-2017
- **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-1088-2017

## Citation

> AI Analytics. FDA recall D-1088-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-1088-2017. Source: US FDA. Licensed CC0.

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