# Bayer de Mexico, S.A. de C.V. · 66-41 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For Bayer de Mexico, S.A. de C.V. · 66-41 · MEXICO, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is MEXICO; product is Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief); product code is 60 C - - 09 Phenylephrine HCl (Adrenergic) | 60 S - - 99 Antacid, N.E.C. | 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic); date published is 09/17/2014; address is Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO, verified against its source on 2026-09-16.

- **Firm:** Bayer de Mexico, S.A. de C.V. _(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:** MEXICO _(verified: appears in the quote below)_
- **Address:** Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO _(verified: appears in the quote below)_
- **Date published:** 09/17/2014 _(verified: appears in the quote below)_
- **Product code:** 60 C - - 09 Phenylephrine HCl (Adrenergic) | 60 S - - 99 Antacid, N.E.C. | 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) _(verified: each item appears in the quote below)_
- **Product:** Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) _(verified: each item appears in the quote below)_
- **FDA notes:** The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. | The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. | The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. _(verified: each item appears in the quote below)_

## What the source says

> Bayer de Mexico, S.A. de C.V. Date Published : 09/17/2014 Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO 60 C - - 09 Phenylephrine HCl (Adrenergic) Date Published: 09/17/2014 Desc: Tabcin Effervescent Tablets (Cold and flu relief) Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. 60 S - - 99 Antacid, N.E.C. Date Published: 09/17/2014 Desc: Tabcin Effervescent Tablets (Cold and flu relief) Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph. 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) Date Published: 09/17/2014 Desc: Tabcin Effervescent Tablets (Cold and flu relief) Notes: The product; as formulated and labeled; appears to be a an unapproved new drug because it does not meet the requirements of the final monograph for Cold; Cough; Allergy; Bronchodilator; and Antiasthmatic Drug Products for OTC use; 21 CFR Part 341. For example; product indications such as the relief of upset stomach; heartburn; acid indigestion; and sour stomach do not meet the indications outlined in the final monograph.

## 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/).