FDA-Drug2016-11-09Class II

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

Akorn Inc
Hazard

Subpotent Drug: concentration of product is less than labeled amount.

Sold states
Nationwide and Puerto Rico
Affected count
29,972 bottles
Manufactured in
1925 W Field Ct, Lake Forest, IL, United States
Products
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0124-2017

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