The Recall Desk
HighFDA (Drugs)·D-0839-2023·Announced 2023-06-07

Proparacaine HCl Ophthalmic Solution Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution 0.5% due to manufacturing deviations. The manufacturer could not complete required stability studies before going 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 is an FDA Class II recall for an ophthalmic medication with unverified stability due to incomplete manufacturing studies. While no illnesses or injuries have been reported, the inability to confirm medication stability represents a potential risk to users.

Plain-English summary

Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles (Rx only). The product was distributed nationwide in the USA and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer was unable to complete required stability studies because the company went out of business.

Stability studies are required to demonstrate that medications maintain their safety, purity, and potency throughout their labeled shelf life. Without completed stability data, the safety and efficacy of this ophthalmic solution cannot be fully confirmed.

The recalled product

Product
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
  • stability-unverified
  • 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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