Reference Source

Healthy America Colombia Sa · 99-39 · COLOMBIA

For Healthy America Colombia Sa · 99-39 · COLOMBIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is COLOMBIA; product is XAMBO 30 Capsules | XAMBO 30 Capsules; product code is 54 A - - 16 Vitamin E (Tocopherol) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 10/19/2016; address is Carrera 3 7 13186 , Yumbo, Valle Del Cauca COLOMBIA, verified against its source on 2026-09-16.

Firm
Healthy America Colombia Sa verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
COLOMBIA verified
Address
Carrera 3 7 13186 , Yumbo, Valle Del Cauca COLOMBIA verified
Date published
10/19/2016 verified
Product code
54 A - - 16 Vitamin E (Tocopherol) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
Product
XAMBO 30 Capsules | XAMBO 30 Capsules each item verified
FDA notes
The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the label fails to declare dimethylamylamine (DMAA) as an ingredient. | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the label fails to declare dimethylamylamine (DMAA) as an ingredient. 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

Healthy America Colombia Sa Date Published : 10/19/2016 Carrera 3 7 13186 , Yumbo, Valle Del Cauca COLOMBIA 54 A - - 16 Vitamin E (Tocopherol) Date Published: 10/19/2016 Desc: XAMBO 30 Capsules Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the label fails to declare dimethylamylamine (DMAA) as an ingredient. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/19/2016 Desc: XAMBO 30 Capsules Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, the label fails to declare dimethylamylamine (DMAA) as an ingredient.

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

Source

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