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Class II: temporary or reversible health riskOngoing

Akorn Proparacaine Hydrochloride Ophthalmic Recall

Proparacaine Hydrochloride Ophthalmic Solution, USP 0

Akorn, Inc. · Gurnee, IL

Risk level
Class II
Reported by FDA
Jan 25, 2023
Recall ID
D-0153-2023
Check your lot numberHow we source this data

Summary

Akorn recalled Proparacaine Hydrochloride Ophthalmic starting Oct 13, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0153-2023 on Jan 25, 2023. Reason: CGMP Deviations:. Status: Ongoing.

Why it was recalled

CGMP Deviations:

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0153-2023
Classification
Class II
Status
Ongoing
Recall initiated
Oct 13, 2022
FDA report date
Jan 25, 2023
Quantity
267,678 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-0153-2023, exactly as published.

Show all FDA fields
City
Gurnee
State
IL
Status
Ongoing
Country
United States
Event ID
90948
Address
5605 Centerpoint Ct Ste A
Code information
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
Postal code
60031-5278
Report date
Jan 25, 2023
Product type
Drugs
Recall number
D-0153-2023
Classification
Class II
Recalling firm
Akorn, Inc.
Product quantity
267,678 bottles
Reason for recall
CGMP Deviations:
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide in the USA
Recall initiation date
Oct 13, 2022
Initial firm notification
Letter
Center classification date
Jan 13, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0153-2023, published Jan 25, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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