The Recall Desk
HighFDA (Drugs)·D-0785-2023·Announced 2023-06-07

Artificial Tears Solution Recalled Due to CGMP Deviations and Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) nationwide due to CGMP compliance issues and inability to complete required stability studies after the firm went out of business.

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 recall involves a risk-of-harm drug product with incomplete stability testing and no reported illnesses or injuries, placing it in the High category per the FDA severity rubric.

Plain-English summary

Akorn, Inc. is recalling all lots of Artificial Tears Solution, Polyvinyl Alcohol 1.4% for ophthalmic use. The product was distributed nationwide in the United States and Puerto Rico.

The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. The firm went out of business and could no longer continue stability studies. All lots and all NDC codes are included in the recall.

Consumers currently using this product should stop and discuss alternatives with their healthcare provider.

The recalled product

Product
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • cgmp-deviation
  • incomplete-stability-studies

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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