HIMALAYA PVT LTD · 66-41 · INDIA
For HIMALAYA PVT LTD · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Himalaya Anti-Dandruff Tea Tree Shampoo | Himalaya Anti-Dandruff Tea Tree Shampoo; product code is 53 E - - -- Hair Preps(Non-Coloring) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/09/2025; address is Makali 562 162 , Bengaluru, INDIA, verified against its source on 2026-09-16.
- Firm
- HIMALAYA PVT LTD verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- INDIA verified
- Address
- Makali 562 162 , Bengaluru, INDIA verified
- Date published
- 06/09/2025 verified
- Product code
- 53 E - - -- Hair Preps(Non-Coloring) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Himalaya Anti-Dandruff Tea Tree Shampoo | Himalaya Anti-Dandruff Tea Tree Shampoo each item verified
- FDA notes
- This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Anti-Dandruff TEA TREE SHAMPOO” “…Tea Tree Oil A natural anti-fungal agent known to fight dandruff…”. | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Anti-Dandruff TEA TREE SHAMPOO” “…Tea Tree Oil A natural anti-fungal agent known to fight dandruff…”. each item verified
What the source says
HIMALAYA PVT LTD Date Published : 06/09/2025 Makali 562 162 , Bengaluru, INDIA 53 E - - -- Hair Preps(Non-Coloring) Date Published: 06/09/2025 Desc: Himalaya Anti-Dandruff Tea Tree Shampoo Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Anti-Dandruff TEA TREE SHAMPOO” “…Tea Tree Oil A natural anti-fungal agent known to fight dandruff…”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/09/2025 Desc: Himalaya Anti-Dandruff Tea Tree Shampoo Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Anti-Dandruff TEA TREE SHAMPOO” “…Tea Tree Oil A natural anti-fungal agent known to fight dandruff…”.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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