# FDA recall D-0975-2016

> **Aidarex Pharmaceuticals LLC** · Class II · drug recall initiated 2016-06-01.

## Product

CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only.  MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.

## Reason for recall

Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

## Distribution

U.S. including: CA, ND, PA, TN

## Key facts

- **Recall number:** D-0975-2016
- **Recalling firm:** Aidarex Pharmaceuticals LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-01
- **Report date:** 2016-06-15
- **Termination date:** 2016-10-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Corona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0975-2016

## Citation

> AI Analytics. FDA recall D-0975-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0975-2016. Source: US FDA. Licensed CC0.

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