Hydrocortisone Ointment
FDA Recall NDC 45802-014
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Hydrocortisone (NDC 45802-014). A significant event, classified as Class II, was initiated on May 07, 2018 by Padagis Israel Pharmaceuticals Ltd. The reported reason for this action was: "Failed Stability Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Stability Specifications
May 07, 2018
May 23, 2018
571,632 tubes
Recall Profile & Regulatory Data
Event ID
80049
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Perrigo New York
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide including Puerto Rico.
Termination Date
Dec 10, 2018
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
45802-004-02Product
45802-004-03Product
45802-014-02Product
45802-014-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
