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.

Recall Number: D-0645-2016

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.

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.