Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01

Recall Number: D-1628-2020

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20201007

Initiation Date: 20200903

Termination Date: 20220801

CGMP Deviations

Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01