Glaxosmithkline · 66-41 · UNITED KINGDOM
For Glaxosmithkline, import alert is 66-41; country is UNITED KINGDOM; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 - - - -- Human and Animal Drugs | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 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 2026-10-01.
- Firm
- Glaxosmithkline verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- UNITED KINGDOM verified
- Address
- G S K House , 980 Great West Road , Brentford, Middlesex UNITED KINGDOM verified
- Date published
- 01/14/2010 verified
- 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 - - - -- Human and Animal Drugs | 63 R - - 04 Sodium Fluoride (Dental Caries Prophylactic) | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs each item verified
- Product
- MacLeans Fresh Mint Toothpaste | MacLeans Fresh Mint Toothpaste each item verified
- 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). | 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). each item verified
What the source says
Glaxosmithkline Date Published : 01/14/2010 G S K House , 980 Great West Road , Brentford, Middlesex UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-24
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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 - - - -- 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). 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).
— all from accessdata.fda.gov, retrieved 2026-09-24
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.