Sandoz Inc recalls Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle ND…

Recall date

October 17, 2019

Source

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

Recall number

D-0161-2020

FDA classification

Class III

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide in the U.S.

Why it was recalled

Labeling: Incorrect or missing package insert.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.