# Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V. · 53-06 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V. · 53-06 · MEXICO, import alert is 53-06; import alert name is "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations"; country is MEXICO; product is Crest Complete 4 in 1 | Crest Complete 4 in 1 | Crest Complete 4 in 1; product code is 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 R - - 99 Dental Caries Prophylactic N.E.C; date published is 05/30/2017; address is San Andres Atoto No. 326 , Colonia San Francisco Cuautlalpan , Naucalpan, State of Mexico MEXICO, verified against its source on 2026-09-16.

- **Firm:** Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V. _(verified: appears in the quote below)_
- **Import alert:** 53-06
- **Import alert name:** "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations"
- **Country:** MEXICO _(verified: appears in the quote below)_
- **Address:** San Andres Atoto No. 326 , Colonia San Francisco Cuautlalpan , Naucalpan, State of Mexico MEXICO _(verified: appears in the quote below)_
- **Date published:** 05/30/2017 _(verified: appears in the quote below)_
- **Product code:** 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 R - - 99 Dental Caries Prophylactic N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Crest Complete 4 in 1 | Crest Complete 4 in 1 | Crest Complete 4 in 1 _(verified: each item appears in the quote below)_
- **FDA notes:** Blue Pigment 15 (C.I. 74160 certifiable as Phthalocyanine (2-1) copper) non-permitted; C.I. 74160 - not permitted Inner ingredient list and list on outer package do not match. Inner list has Blue Pigment 15 (CI 74160) and is not permitted in drugs. | Blue Pigment 15 (C.I. 74160 certifiable as Phthalocyanine (2-1) copper) non-permitted; C.I. 74160 - not permitted Inner ingredient list and list on outer package do not match. Inner list has Blue Pigment 15 (CI 74160) and is not permitted in drugs | Blue Pigment 15 (C.I. 74160 certifiable as Phthalocyanine (2-1) copper) non-permitted; C.I. 74160 - not permitted Inner ingredient list and list on outer package do not match. Inner list has Blue Pigment 15 (CI 74160) and is not permitted in drugs _(verified: each item appears in the quote below)_

## What the source says

> Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V. Date Published : 05/30/2017 San Andres Atoto No. 326 , Colonia San Francisco Cuautlalpan , Naucalpan, State of Mexico MEXICO 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 05/30/2017 Desc: Crest Complete 4 in 1 Notes: Blue Pigment 15 (C.I. 74160 certifiable as Phthalocyanine (2-1) copper) non-permitted; C.I. 74160 - not permitted Inner ingredient list and list on outer package do not match. Inner list has Blue Pigment 15 (CI 74160) and is not permitted in drugs. 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) Date Published: 05/30/2017 Desc: Crest Complete 4 in 1 Notes: Blue Pigment 15 (C.I. 74160 certifiable as Phthalocyanine (2-1) copper) non-permitted; C.I. 74160 - not permitted Inner ingredient list and list on outer package do not match. Inner list has Blue Pigment 15 (CI 74160) and is not permitted in drugs 63 R - - 99 Dental Caries Prophylactic N.E.C. Date Published: 05/30/2017 Desc: Crest Complete 4 in 1 Notes: Blue Pigment 15 (C.I. 74160 certifiable as Phthalocyanine (2-1) copper) non-permitted; C.I. 74160 - not permitted Inner ingredient list and list on outer package do not match. Inner list has Blue Pigment 15 (CI 74160) and is not permitted in drugs

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_130.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/).