FDA recall D-0666-2016

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

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

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