Hydrocortisone Cream Intensive Healing Cream
FDA Recall NDC 0363-0237
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 Cream Intensive Healing (NDC 0363-0237). A significant event, classified as Class II, was initiated on Dec 07, 2018 by Walgreens. The reported reason for this action was: "GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample"
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
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Dec 07, 2018
Feb 13, 2019
67848 units
Recall Profile & Regulatory Data
Event ID
81784
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
US Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Nov 06, 2023
Product Description
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03
Batch or Lot Expiration Information
Lot# : 36G17, 47G17, Exp. 5/2019; 84J17, Exp. 7/2019
Affected Packages Involved in this Recall
0363-0237-02Product
0363-0237-03Product
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.
