Medicines defect noticeMHRA
Duraphat 5000ppm Fluoride Toothpaste (51g) defect notice over a labelling error
Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above are missing information relating to the presence of allergens in the product.
Check your product
Only products that match these details are covered. Have your pack in front of you.
37 identifiers listed for this notice.
Duraphat 5000ppm Fluoride Toothpaste (51g) 1
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 3011FR63A1
- 3026FR63A1
- 3031FR63A1
- 3047FR63A1
- 3053FR63A1
- 3060FR63A1
- 3061FR63A1
- 3061FR63A2
- 3068FR63A1
- 3082FR63A1
- 3081FR63A1
- 3096FR63A1
- 3096FR63B1
- 3102FR63A1
- 3103FR63A1
- 3108FR63A1
- 3110FR63A1
- 3131FR63A1
- 3123FR63A1
- 3172FR63A1
- Product licenceThe PL number on the carton.
- PL 00049/0050
- ExpiryOn the carton, blister or label.
- 12/2025
- 01/2026
- 02/2026
- 03/2026
- 04/2026
- 05/2026
- First distributedOn the product, its label or its packaging.
- 16/02/2023
- 07/06/2023
- 12/04/2023
- 29/03/2023
- 24/04/2023
- 27/04/2023
- 30/05/2023
- 05/06/2023
- 03/07/2023
- Not yet Distributed
What to do now
A printing or labelling mistake affects some packs of Duraphat 5000ppm Fluoride Toothpaste (51g).
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(23)A/35). Quoted as issued.
Summary
Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above are missing information relating to the presence of allergens in the product.
The risk
MDR number MDR 201-08/23 Company name
Advice for healthcare professionals
Healthcare professionals are advised to note the updated information. Where appropriate, inform patients about it, provide them with an updated copy of the PIL, and remind them to read the leaflet in its entirety before using the medicine. This notification relates to multiple batches and there is no expectation that you contact patients directly.
Upon request, the manufacturer will post hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. Contact Colgate-Palmolive’s customer contact facilities (00800 321 321 32) to request hard copies.
The correct PIL is also available via https://www.colgate.com/en-gb/products/specialty/duraphat-product-labelling-update to enable healthcare professionals to provide it to patients directly.
The manufacturer has confirmed that the batches that have yet to be distributed will be accompanied by a note explaining the issue along with a copy of the correct PIL, to supplement dispensing at pharmacies. These batches will not be repackaged to avoid any supply concerns. The manufacturer has confirmed that all future batches will be packaged with the correct PIL.
Patients should be aware that batches of Duraphat 5000ppm Fluoride Toothpaste (51g) are missing important safety information after changes were made to the information that needs to be included. The Patient Information Leaflet (PIL), carton and tube of the product do not include information about the presence of allergens in the product, and the PIL is missing information relating to the concentration of Sodium Benzoate.
You can access the updated PIL via https://www.colgate.com/en-gb/products/specialty/duraphat-product-labelling-update . Patients can request a copy of the updated PIL or ask questions about the product by contacting Colgate-Palmolive’s customer contact facilities on 00800 321 321 32 or via https://www.colgatepalmolive.co.uk/contact-us
Patients should continue to use the impacted batches of Duraphat 5000ppm Fluoride Toothpaste (51g) as prescribed. If you have any questions about your medicine or are concerned about side effects, talk to your healthcare professional.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
Patients should be aware that batches of Duraphat 5000ppm Fluoride Toothpaste (51g) are missing important safety information after changes were made to the information that needs to be included. The Patient Information Leaflet (PIL), carton and tube of the product do not include information about the presence of allergens in the product, and the PIL is missing information relating to the concentration of Sodium Benzoate.
You can access the updated PIL via https://www.colgate.com/en-gb/products/specialty/duraphat-product-labelling-update . Patients can request a copy of the updated PIL or ask questions about the product by contacting Colgate-Palmolive’s customer contact facilities on 00800 321 321 32 or via https://www.colgatepalmolive.co.uk/contact-us
Patients should continue to use the impacted batches of Duraphat 5000ppm Fluoride Toothpaste (51g) as prescribed. If you have any questions about your medicine or are concerned about side effects, talk to your healthcare professional.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Duraphat 5000ppm Fluoride Toothpaste (51g) been recalled?
A printing or labelling mistake affects some packs of Duraphat 5000ppm Fluoride Toothpaste (51g). Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, product licence, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.