DERMLITE DL4W recalled over labeling errors

Recall date

March 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DermLite LLC recalls DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

Recall number

Z-1506-2023

FDA classification

Class II

Brand / firm

DermLite LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.

Why it was recalled

Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DERMLITE DL4W, REF: DL4W, Rx Only MD, CE