# Pharmcle Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Pharmcle Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is ZAPS Sanitizer Spray | ZAPS Sanitizer Spray; product code is 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical; date published is 08/24/2020; address is 106 Sandanro67beon-Gil; Danwon , Ansan, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Pharmcle Co., Ltd. _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 106 Sandanro67beon-Gil; Danwon , Ansan, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/24/2020 _(verified: appears in the quote below)_
- **Product code:** 62 H - - 05 Ethyl Alcohol (Anti-Microbial) | 95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical _(verified: each item appears in the quote below)_
- **Product:** ZAPS Sanitizer Spray | ZAPS Sanitizer Spray _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus. | The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus. _(verified: each item appears in the quote below)_

## What the source says

> Pharmcle Co., Ltd. Date Published : 08/24/2020 106 Sandanro67beon-Gil; Danwon , Ansan, Gyeonggi KOREA (THE REPUBLIC OF) 62 H - - 05 Ethyl Alcohol (Anti-Microbial) Date Published: 08/24/2020 Desc: ZAPS Sanitizer Spray Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus. 95 R - - GI Hand Washing Sanitizer, Ultraviolet Hygiene Products, Non-Medical Date Published: 08/24/2020 Desc: ZAPS Sanitizer Spray Notes: The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): 'Disinfection of hands and skin', and '99.9% Sterilization of bacteria and viruses'. In addition, the product's principal display panel contains a depiction of the novel coronavirus with a slash in the middle, which suggests that the product is effective in preventing infection or disease specifically from the novel coronavirus.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).