PlainRecalls
FDA Drug Moderate Class II Terminated

Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.

Reported: November 9, 2016 Initiated: October 21, 2016 #D-0124-2017

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.

Details

Recalling Firm
Akorn Inc
Units Affected
29,972 bottles
Distribution
Nationwide and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.. Recalled by Akorn Inc. Units affected: 29,972 bottles.
Why was this product recalled?
Subpotent Drug: concentration of product is less than labeled amount.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 9, 2016. Severity: Moderate. Recall number: D-0124-2017.