Reference Source

Procter & Gamble Manufacturing Mexico, S. de R.L. de C.V. · 53-06 · MEXICO

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
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
Address
San Andres Atoto No. 326 , Colonia San Francisco Cuautlalpan , Naucalpan, State of Mexico MEXICO verified
Date published
05/30/2017 verified
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. each item verified
Product
Crest Complete 4 in 1 | Crest Complete 4 in 1 | Crest Complete 4 in 1 each item verified
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 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

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

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

Source

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