Product: Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.
Reason for recall: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Recall initiated: 20160118
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated