Reference Source

Glaxo SmithKline Ltd · 99-39 · INDIA

For Glaxo SmithKline Ltd · 99-39 · INDIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is INDIA; product is Boost Drink Powder | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks; product code is 30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C. | 30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C. | 34 H - - 02 Chocolate Dairy Mix | 34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 C - - 99 Foods (including Water) with Excessive Nutritional Claims | 41 E - - 99 Meal Replacements (Not labeled for treatment of disease); date published is 10/02/2015; address is Nobha , Patiyala Road , Nabha, Punjab INDIA, verified against its source on 2026-09-16.

Firm
Glaxo SmithKline Ltd verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
INDIA verified
Address
Nobha , Patiyala Road , Nabha, Punjab INDIA verified
Date published
10/02/2015 verified
Product code
30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C. | 30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C. | 34 H - - 02 Chocolate Dairy Mix | 34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 C - - 99 Foods (including Water) with Excessive Nutritional Claims | 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) each item verified
Product
Boost Drink Powder | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks | Horlicks Drinks each item verified
FDA notes
1/25/2016; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that it does not bear a Nutrition Facts label as required in 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) because many of the ingredients are not declared in accordance with 21 CFR 101.4. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act because the product fails to bear the common or usual name of the food [21 CFR 101.3(a)]. | VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). | VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). | VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). | VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). | VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). | VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). each item verified
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DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Glaxo SmithKline Ltd Date Published : 10/02/2015 Nobha , Patiyala Road , Nabha, Punjab INDIA 30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C. Date Published: 12/14/2023 Desc: Boost Drink Powder Notes: 1/25/2016; The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(q) of the Act in that it does not bear a Nutrition Facts label as required in 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(2) because many of the ingredients are not declared in accordance with 21 CFR 101.4. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food; Drug; and Cosmetic Act (the Act) in that it appears to be misbranded within the meaning of section 403(i)(1) of the Act because the product fails to bear the common or usual name of the food [21 CFR 101.3(a)]. 30 Y - - 99 Beverage Base Not Mentioned Elsewhere, N.E.C. Date Published: 10/02/2015 Desc: Horlicks Drinks Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). 34 H - - 02 Chocolate Dairy Mix Date Published: 10/02/2015 Desc: Horlicks Drinks Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). 34 H - - 99 Chocolate and Cocoa Beverage Base, N.E.C. Date Published: 10/02/2015 Desc: Horlicks Drinks Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/02/2015 Desc: Horlicks Drinks Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). 41 C - - 99 Foods (including Water) with Excessive Nutritional Claims Date Published: 10/02/2015 Desc: Horlicks Drinks Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor). 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) Date Published: 10/02/2015 Desc: Horlicks Drinks Notes: VIOLATION -- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of section 403(q) of the Act because the labels do not comply with the nutrition labeling requirements in 21 CFR 101.9; (e.g.; nutrition information is not based on the correct RACC; required nutrients are missing; and daily values) and the firm is not exempt from this requirement. In addition; the article is subject to refusal of admission pursuant to Section 801 (a)(3) in that it appears to be misbranded within the meaning of section 403(i)(2) of the Act because the labels fail to list the ingredients by their common or usual name in descending order of predominance by weight on either the principal display panel or the information panel; as required by 21 CFR 101.4. The regulation does not provide for listing ingredients by category (e.g.; vitamins; minerals or flavor).

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

Source

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