Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39

Recall Number: D-0010-2017

Firm: Leiter's Compounding

Classification: Class II

Status: Terminated

Report Date: 20161019

Initiation Date: 20160920

Termination Date: 20170503

Reason for Recall

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Product Description

Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39