# FDA recall D-0613-2018

> **Akorn, Inc.** · Class III · drug recall initiated 2018-03-29.

## Product

24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA  30004; Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004, Product 97014.

## Reason for recall

Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0613-2018
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-29
- **Report date:** 2018-04-04
- **Termination date:** 2020-04-22

- **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-0613-2018

## Citation

> AI Analytics. FDA recall D-0613-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0613-2018. Source: US FDA. Licensed CC0.

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