# Wellous Pharma Pvt. Ltd. · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** 7/62-B, Villianur Road , Perambai Village, INDIA _(verified: appears in the quote below)_
- **Date published:** 03/19/2021 _(verified: appears in the quote below)_
- **Product code:** 60 S - - 99 Antacid, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants | Woodward's Celebrated "Gripe Water"; Gentle Antacid Safe for Infants _(verified: each item appears in the quote below)_
- **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...". _(verified: each item appears in the quote below)_

## 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...".

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).