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Class II: temporary or reversible health riskTerminated

Akorn Eye Itch Relief Recall

Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0

Akorn, Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Oct 7, 2020
Recall ID
D-1628-2020
Check your lot numberHow we source this data

Summary

Akorn recalled Eye Itch Relief starting Sep 3, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1628-2020 on Oct 7, 2020. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01

Lot numbers, UPCs & expiration codes

Lot 8A11A exp 12/20

Where it was sold

Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC

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-1628-2020
Classification
Class II
Status
Terminated
Recall initiated
Sep 3, 2020
FDA report date
Oct 7, 2020
Quantity
25,843 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn, Inc.

Original FDA data

Every field from FDA enforcement report D-1628-2020, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
86361
Address
1925 W Field Ct Ste 300
Code information
Lot 8A11A exp 12/20
Postal code
60045-4862
Report date
Oct 7, 2020
Product type
Drugs
Recall number
D-1628-2020
Classification
Class II
Recalling firm
Akorn, Inc.
Product quantity
25,843 bottles
Termination date
Aug 1, 2022
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
Distribution pattern
Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC
Recall initiation date
Sep 3, 2020
Initial firm notification
Letter
Center classification date
Sep 30, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1628-2020, published Oct 7, 2020. 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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