Sandoz Inc recalls Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC
Recalled November 6, 2019 · FDA recall D-0161-2020 · Sandoz
Hazard
Labeling: Incorrect or missing package insert. · FDA Class III
Units
346,929 bottles
Sold at
Nationwide in the U.S.
Description
Labeling: Incorrect or missing package insert.
Product
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.
Manufacturer(s)
Sandoz Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →