# FDA recall D-0666-2016

> **Alcon Research, Ltd.** · Class II · drug recall initiated 2016-02-09.

## Product

TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX  76134, Barcode 90016741106, UPC 3 00650 41636 8.

## Reason for recall

Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0666-2016
- **Recalling firm:** Alcon Research, Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-09
- **Report date:** 2016-02-24
- **Termination date:** 2017-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0666-2016

## Citation

> AI Analytics. FDA recall D-0666-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0666-2016. Source: US FDA. Licensed CC0.

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