# FDA recall D-0514-2017

> **Actavis Inc** · Class III · drug recall initiated 2017-02-07.

## Product

Levofloxacin Ophthalmic Solution, 0.5%, Sterile,  packaged in 5mL bottles, Rx Only, Manufactured by  Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05

## Reason for recall

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18  month stability time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0514-2017
- **Recalling firm:** Actavis Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-07
- **Report date:** 2017-03-15
- **Termination date:** 2018-01-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0514-2017

## Citation

> AI Analytics. FDA recall D-0514-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0514-2017. Source: US FDA. Licensed CC0.

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