Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Wal...
FDA Recall #D-0426-2019 — Class II — December 7, 2018
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
Recalling Firm
US Pharmaceuticals Inc. — Belleville, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
67848 units
Distribution
Nationwide within the United States
Code Information
Lot #: 36G17, 47G17, Exp. 5/2019; 84J17, Exp. 7/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated