PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 13, 2019 Initiated: December 7, 2018 #D-0426-2019

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

Reason for Recall

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Details

Recalling Firm
US Pharmaceuticals Inc.
Units Affected
67848 units
Distribution
Nationwide within the United States
Location
Belleville, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by US Pharmaceuticals Inc.. Units affected: 67848 units.
Why was this product recalled?
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Which agency issued this recall?
This recall was issued by the FDA Drug on February 13, 2019. Severity: Moderate. Recall number: D-0426-2019.