The Recall Desk
HighFDA (Drugs)·D-0786-2023·Announced 2023-06-07

FDA Recalls All Lots Akorn Artificial Tears Ointment Nationwide

Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required stability studies.

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: This is an FDA Class II recall of a sterile ophthalmic product where manufacturing compliance studies could not be completed. No illnesses or injuries have been reported. This meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Akorn, Inc. is recalling all lots of its Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, distributed nationwide in the USA and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer continue the stability studies required for this product.

Concerned consumers should contact their healthcare provider about this recall and any appropriate alternatives.

The recalled product

Product
Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • cgmp-deviation
  • incomplete-stability-testing

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.

Related recalls

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