The Recall Desk
Agency classClass IIOur severity: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.

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 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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