Maximum Strength Hydrocortisone Cream With Aloe Cream
FDA Recall NDC 0363-0620
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Maximum Strength Hydrocortisone Cream With Aloe (NDC 0363-0620). A significant event, classified as Class II, was initiated on Jul 11, 2019 by Walgreens. The reported reason for this action was: "CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process."
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
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Jul 11, 2019
Aug 21, 2019
3114 cases
Recall Profile & Regulatory Data
Event ID
83316
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
US Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jun 25, 2020
Product Description
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3
Batch or Lot Expiration Information
Lot# 63J17 EXP 07/2019, 11P17 EXP 11/2019
Affected Packages Involved in this Recall
0363-0620-01Product
0363-0620-03Product
Class II Terminated
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Jul 11, 2019
Aug 21, 2019
1223 cases
Recall Profile & Regulatory Data
Event ID
83316
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
US Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jun 25, 2020
Product Description
Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6
Batch or Lot Expiration Information
Lot# 's 11P17, 20P17 EXP 11/2019
Affected Packages Involved in this Recall
0363-0620-02Product
0363-0620-04Product
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.
