# Glaxosmithkline · 66-41 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For Glaxosmithkline · 66-41 · UNITED KINGDOM, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is UNITED KINGDOM; product is MacLeans Fresh Mint Toothpaste | MacLeans Fresh Mint Toothpaste; product code is 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 01/14/2010; address is G S K House , 980 Great West Road , Brentford, Middlesex UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Glaxosmithkline _(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:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** G S K House , 980 Great West Road , Brentford, Middlesex UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 01/14/2010 _(verified: appears in the quote below)_
- **Product code:** 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs _(verified: each item appears in the quote below)_
- **Product:** MacLeans Fresh Mint Toothpaste | MacLeans Fresh Mint Toothpaste _(verified: each item appears in the quote below)_
- **FDA notes:** Country; United Kingdom The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | Country; United Kingdom The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). | The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). _(verified: each item appears in the quote below)_

## What the source says

> Glaxosmithkline Date Published : 01/14/2010 G S K House , 980 Great West Road , Brentford, Middlesex UNITED KINGDOM 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 01/14/2010 Desc: MacLeans Fresh Mint Toothpaste Notes: Country; United Kingdom The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/27/2022 60 - - - -- Human and Animal Drugs Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 61 - - - -- Human and Animal Drugs Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 62 - - - -- Human and Animal Drugs Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) Date Published: 01/14/2010 Desc: MacLeans Fresh Mint Toothpaste Notes: Country; United Kingdom The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 63 - - - -- Human and Animal Drugs Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 64 - - - -- Human and Animal Drugs Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 65 - - - -- Human and Animal Drugs Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1). 66 - - - -- Human and Animal Drugs Date Published: 01/14/2010 Notes: The product label states the product contains sodium fluoride (0.306%,w/w (1400 ppm fluoride)) which exceeds the acceptable limit set in regulation (21) CFR 355.10(a)(1).

## 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/).