FDA recall D-0426-2019

Product

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-12-07

Report date

2019-02-13

Termination date

2023-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belleville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2019