FDA recall Z-0088-2019

Product

Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.

Reason for recall

Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

Distribution

United States, Taiwan, Chile

Key facts

Status

Terminated

Initiation date

2018-08-30

Report date

2018-10-17

Termination date

2023-02-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2019