Octiq Lubricating Eye Drops recalled over sterility concerns

Recall date

September 1, 2023

Source

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

Official notice title

AMMAN PHARMACEUTICAL INDUSTRIES recalls octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Inn…

Recall number

D-1167-2023

FDA classification

Class II

Brand / firm

AMMAN PHARMACEUTICAL INDUSTRIES

Sold / distributed

Product was distributed to two (2) direct accounts in RI and CO.

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.