Reference Source

Handok Pharmaceuticals Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF)

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
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
Address
unknown , Chungchongbuk, KOREA (THE REPUBLIC OF) verified
Date published
08/05/2019 verified
Product code
64 E - - 01 Cellulase (Enzyme) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Festal Plus Tablets | Festal Plus Tablets each item verified
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...'. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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...'.

accessdata.fda.gov, retrieved 2026-09-15

Source

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