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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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