Product: Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.
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