The Recall Desk
HighFDA (Drugs)·D-0845-2023·Announced 2023-06-07

Sodium Chloride Ophthalmic Solution Recalled Due to Incomplete Stability Studies

Akorn Operating Company is recalling all lots of Sodium Chloride Ophthalmic Solution (5%, 50mg/mL) nationwide because the firm went out of business and could not complete required stability studies to verify product safety and effectiveness.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Although no illnesses or injuries have been reported, this is a medical pharmaceutical product classified as FDA Class II. The inability to complete required stability studies for an ophthalmic solution creates a risk-of-harm to the eye if the product has degraded or lost its safety properties, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Akorn Operating Company LLC is recalling all lots of Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL in 15 mL bottles distributed nationwide in the USA and Puerto Rico. The recall is being issued because the firm went out of business and could no longer conduct stability studies—testing necessary to confirm the product remains safe and effective during storage.

Sodium chloride ophthalmic solutions are eye drops used to relieve eye irritation. Without completed stability studies, there is uncertainty about whether the product may have degraded during storage or retained its pharmaceutical properties.

Patients currently using this product should consult their healthcare provider or pharmacist for advice about alternative treatments. Healthcare providers should stop dispensing this product and should identify and contact affected patients. Anyone with this product should not use it and should return it to their pharmacy or consult with their healthcare provider for further guidance.

The recalled product

Product
Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • stability-unproven
  • cgmp-deviation

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

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