Reference Source

Wellous Pharma Pvt. Ltd. · 66-41 · INDIA

For Wellous Pharma 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 Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants | Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants; product code is 60 S - - 99 Antacid, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 03/19/2021; address is 7/62-B, Villianur Road , Perambai Village, INDIA, verified against its source on 2026-09-16.

Firm
Wellous Pharma 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
7/62-B, Villianur Road , Perambai Village, INDIA verified
Date published
03/19/2021 verified
Product code
60 S - - 99 Antacid, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants | Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants each item verified
FDA notes
The product appears to be an unapproved new drug, as its promotional website includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid...". | The product appears to be an unapproved new drug, as its promotional website includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid...". 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

Wellous Pharma Pvt. Ltd. Date Published : 03/19/2021 7/62-B, Villianur Road , Perambai Village, INDIA 60 S - - 99 Antacid, N.E.C. Date Published: 03/19/2021 Desc: Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid...". 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/19/2021 Desc: Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants Notes: The product appears to be an unapproved new drug, as its promotional website includes claims such as: "Gives instant relief to infants and babies ... due to gripe", "Relieve stomach pain caused by acidity and indigestion" and "Gentle antacid...".

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

Source

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