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.

Recall Number: D-0647-2016

Firm: Bausch & Lomb, Inc.

Classification: Class III

Status: Terminated

Report Date: 20160203

Initiation Date: 20160118

Termination Date: 20200106

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

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.