FDA recall D-0161-2020

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.

Reason for recall

Labeling: Incorrect or missing package insert.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2019-10-17

Report date

2019-11-06

Termination date

2022-01-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0161-2020