Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest...
FDA Recall #D-0124-2017 — Class II — October 21, 2016
Product Description
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Reason for Recall
Subpotent Drug: concentration of product is less than labeled amount.
Recalling Firm
Akorn Inc — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
29,972 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot: 041306A, Exp 04/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated