Bausch & Lomb, Inc. recalls Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 242…

Recall date

January 18, 2016

Source

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

Recall number

D-0647-2016

FDA classification

Class III

Brand / firm

Bausch & Lomb, Inc.

Sold / distributed

U.S. Nationwide including Puerto Rico.

Why it was recalled

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

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

What was recalled

Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.