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

For Handok Pharmaceuticals 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 Festal Plus Tablets | Festal Plus Tablets; product code is 64 E - - 01 Cellulase (Enzyme) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 08/05/2019; address is unknown , Chungchongbuk, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Handok Pharmaceuticals 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:** unknown , Chungchongbuk, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/05/2019 _(verified: appears in the quote below)_
- **Product code:** 64 E - - 01 Cellulase (Enzyme) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Festal Plus Tablets | Festal Plus Tablets _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'. | The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'. _(verified: each item appears in the quote below)_

## What the source says

> Handok Pharmaceuticals Co., Ltd. Date Published : 08/05/2019 unknown , Chungchongbuk, KOREA (THE REPUBLIC OF) 64 E - - 01 Cellulase (Enzyme) Date Published: 08/05/2019 Desc: Festal Plus Tablets Notes: The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/05/2019 Desc: Festal Plus Tablets Notes: The product appears to be an unapproved new drug as the product contains the active ingredient pancreatin and the product label notes the product's intended use as a digestive aid by listing (not an all-inclusive list); '...Uses; Digestion...'.

## 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/).