The Recall Desk
ModerateFDA (Drugs)·D-0124-2017·Announced 2016-11-09

Akorn Recalls Subpotent Sodium Chloride Ophthalmic Solution

Akorn Inc. is recalling 29,972 bottles of 5% Sodium Chloride Ophthalmic Solution because the product concentration is less than the labeled amount.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a subpotent drug.

Plain-English summary

Akorn Inc. is recalling 29,972 bottles of Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL. The recall is due to the product being subpotent, meaning the concentration of the active ingredient is less than the amount stated on the label.

The affected product is identified by Lot 041306A and has an expiration date of 04/19. The NDC number is 17478-623-12. The product was distributed nationwide and in Puerto Rico.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Manufacturer
Akorn Inc
Category
Drug — Ophthalmic Solution
Hazard
Affected units
29,972

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 041306A
  • Exp 04/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Akorn Inc

See all →

Same hazard · subpotent drug

See all →