FDA recall D-1384-2022

Family Dollar Stores, Llc. · Class II · drug

Product

FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2022-06-23
Report date: 2022-08-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chesapeake, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1384-2022