TEARS Naturale FREE lubricant eye drops recalled over sterility concerns

Recall date

February 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Alcon Research, Ltd. recalls TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.0…

Recall number

D-0666-2016

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.