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Class II: temporary or reversible health riskTerminated

Perrigo New York Hydrocortisone Ointment Recall

Hydrocortisone Ointment, USP 2

Perrigo New York · Bronx, NY

Risk level
Class II
Reported by FDA
May 23, 2018
Recall ID
D-0817-2018
Check your lot numberHow we source this data

Summary

Perrigo New York recalled Hydrocortisone Ointment starting May 7, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0817-2018 on May 23, 2018. Reason: Failed Stability Specifications. Status: Terminated.

Why it was recalled

Failed Stability Specifications

Product description

Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02

Lot numbers, UPCs & expiration codes

Lot Numbers: 7AT0283V, exp. 11/18 7AT0284V, exp. 11/18 7AT0285V, exp. 11/18 7FT0460, exp. 05/19 7FT0461, exp. 05/19 7GT0465, exp. 06/19 7GT0466, exp. 06/19 7JT0390, exp. 08/19 7JT0392, exp. 08/19 7KT0588, exp. 09/19 7KT0589, exp. 09/19

Where it was sold

US Nationwide including Puerto Rico.

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-0817-2018
Classification
Class II
Status
Terminated
Recall initiated
May 7, 2018
FDA report date
May 23, 2018
Quantity
571,632 tubes
Recall type
Voluntary: Firm initiated
Recalling firm
Perrigo New York

Original FDA data

Every field from FDA enforcement report D-0817-2018, exactly as published.

Show all FDA fields
City
Bronx
State
NY
Status
Terminated
Country
United States
Event ID
80049
Address
1700 Bathgate Ave
Code information
Lot Numbers: 7AT0283V, exp. 11/18 7AT0284V, exp. 11/18 7AT0285V, exp. 11/18 7FT0460, exp. 05/19 7FT0461, exp. 05/19 7GT0465, exp. 06/19 7GT0466, exp. 06/19 7JT0390, exp. 08/19 7JT0392, exp. 08/19 7KT0588, exp. 09/19 7KT0589, exp. 09/19
Postal code
10457-7512
Report date
May 23, 2018
Product type
Drugs
Recall number
D-0817-2018
Classification
Class II
Recalling firm
Perrigo New York
Product quantity
571,632 tubes
Termination date
Dec 10, 2018
Reason for recall
Failed Stability Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02
Distribution pattern
US Nationwide including Puerto Rico.
Recall initiation date
May 7, 2018
Initial firm notification
Letter
Center classification date
May 16, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0817-2018, published May 23, 2018. 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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