Bayer de Mexico, S.A. de C.V. · 66-41 · MEXICO
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
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- MEXICO verified
- Address
- Carretera Mexico-Toluca Km. 52.5 , Lerma, Mexico MEXICO verified
- Date published
- 09/17/2014 verified
- Product code
- 60 C - - 09 Phenylephrine HCl (Adrenergic) | 60 S - - 99 Antacid, N.E.C. | 61 X - - 08 Chlorpheniramine Maleate (Anti-Histaminic) each item verified
- Product
- Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) | Tabcin Effervescent Tablets (Cold and flu relief) each item verified
- 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. each item verified
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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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