David Cosmetic Co., Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA laboratory testing of a batch of this product in U.S. distribution found that the drug product contained impurities at unacceptable levels. Benzene impurity levels were found to be approximately 6 parts per million (ppm).

Passage 2

In response to FDA’s request during the teleconference for impurity testing results, you responded in a December 29, 2021 communication, stating that you do not conduct impurity testing, including for benzene, of active pharmaceutical ingredients or for your finished hand sanitizer drug products.

Passage 3

As of the date of this letter, you have yet to initiate a recall.