# FDA recall D-1061-2016

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

## Product

Ciprofloxacin OPTH 0.3%  SOL, generic for: Ciloxan, Rx Only,  2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01

## Reason for recall

Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1061-2016
- **Recalling firm:** Aidarex Pharmaceuticals LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-06-01
- **Report date:** 2016-07-06
- **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-1061-2016

## Citation

> AI Analytics. FDA recall D-1061-2016. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1061-2016. Source: US FDA. Licensed CC0.

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