Reference Source

Yunnun Druos Works · 66-41 · CHINA

For Yunnun Druos Works · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product is Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules; product code is 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) | 64 L - - 19 Dexamethasone (Glucocorticoid) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/16/2015; address is 389 Xin Yang Rd. , Yunnun, CHINA, verified against its source on 2026-09-16.

Firm
Yunnun Druos Works verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
CHINA verified
Address
389 Xin Yang Rd. , Yunnun, CHINA verified
Date published
06/16/2015 verified
Product code
54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) | 64 L - - 19 Dexamethasone (Glucocorticoid) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules | Ginseng She Lian Wan Capsules each item verified
FDA notes
The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. | The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. | The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. | The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. | The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. 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

Yunnun Druos Works Date Published : 06/16/2015 389 Xin Yang Rd. , Yunnun, CHINA 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals Date Published: 06/16/2015 Desc: Ginseng She Lian Wan Capsules Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/16/2015 Desc: Ginseng She Lian Wan Capsules Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) Date Published: 06/16/2015 Desc: Ginseng She Lian Wan Capsules Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. 64 L - - 19 Dexamethasone (Glucocorticoid) Date Published: 06/16/2015 Desc: Ginseng She Lian Wan Capsules Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/16/2015 Desc: Ginseng She Lian Wan Capsules Notes: The aforementioned product appears to be an unapproved new drug as FDA analysis found undeclared chlorpheniramine and dexamethasone in the product. In addition; the aforementioned product appears to be an unapproved new drug as the product label implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of the product's intended use from the product label include but are not limited to the following; 'INDICATIONS; Traditionally use for lumbago; gout; arthrodynia; myasthenia; limb numbness; pains induced by acclimation fever and rheumatism; osteocope and arthritis'.

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

Source

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