FDAClass IINovember 9, 2016

Sodium Chloride Ophthalmic Solution recall: Subpotent

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

Why was Sodium Chloride Ophthalmic Solution recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 041306A, Exp 04/19

Product
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Recalling firm
Akorn Inc
Quantity
29,972 bottles
Distribution
Nationwide and Puerto Rico
Recall date
November 9, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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