# FDA recall D-1060-2016

> **Actavis Pharma Inc** · Class III · drug recall initiated 2016-03-16.

## Product

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10

## Reason for recall

Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1060-2016
- **Recalling firm:** Actavis Pharma Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-16
- **Report date:** 2016-07-06
- **Termination date:** 2018-06-13

- **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-1060-2016

## Citation

> AI Analytics. FDA recall D-1060-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-1060-2016. Source: US FDA. Licensed CC0.

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