The Recall Desk
HighFDA (Drugs)·D-0153-2023·Announced 2023-01-25

Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations

Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.

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: FDA Class II indicates a potential for serious adverse health consequences, but no illnesses, injuries, or hospitalizations are reported in the source. CGMP deviations on a sterile ophthalmic solution represent a risk-of-harm product where injury has not yet been documented.

Plain-English summary

Akorn, Inc. is voluntarily recalling Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% in 15 mL dropper bottles (NDC 17478-263-12). The recall encompasses approximately 267,678 bottles distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The firm initially notified the FDA by letter, and the FDA classified this as a Class II recall.

This is a prescription ophthalmic anesthetic solution used by healthcare providers. Affected lot numbers include 0L42A, 0L50A, 1C64A, 1C76A, 1G53A, 1J26A, 1J25A, 1J48A, and 1J54A. Patients and healthcare providers with this product should consult their pharmacy or eye care provider regarding alternative options.

The recalled product

Product
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Anesthetic Solution
Hazard
Affected units
267,678

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 (13)

  • Lot: 0L42A
  • 0L50A
  • EXP 10/31/2022
  • 1C64A
  • 1C76A
  • EXP 2/28/2023
  • 1G53A
  • EXP 6/30/2023
  • 1J26A
  • 1J25A
  • 1J48A
  • 1J54A
  • EXP 8/31/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 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 27 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · cgmp deviation

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