Reported Jan 25, 2023 · Ongoing

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake…

Akorn, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn, Inc. · 5605 Centerpoint Ct Ste A · Gurnee, IL · 60031-5278

Is this the product you have?

  • Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only
  • Manufactured byAkorn, Inc., Lake Forest, IL 60045
  • Distributed ByMWI Boise, ID 83705
  • NDC13985-611-15
Lot codes and dates
  • Lot
    • 0L53A
    • EXP 10/31/2022
    • 1J49A
    • EXP 8/31/2023
Amount recalled
23,026 bottles

This recall covers 27 products

The agency filed one notice per product. You are reading one of them; the other 26 are below.

14 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations:

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.