# FDA recall D-0875-2016

> **Akorn, Inc.** · Class II · drug recall initiated 2016-03-23.

## Product

Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16

## Reason for recall

Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0875-2016
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-23
- **Report date:** 2016-06-01
- **Termination date:** 2017-11-30

- **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-0875-2016

## Citation

> AI Analytics. FDA recall D-0875-2016. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0875-2016. Source: US FDA. Licensed CC0.

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