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