Class 4 Medicines Defect Information: Colgate-Palmolive (U.K.) Limited, Duraphat 5000ppm Fluoride Toothpaste (51g), EL (23)A/35
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.
MDR number
MDR 201-08/23
Company name
Colgate-Palmolive (U.K.) Limited
Product name
Duraphat 5000ppm Fluoride Toothpaste (51g), PL 00049/0050
SNOMED Code
10770611000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 3011FR63A1 | 12/2025 | 1 | 16/02/2023 |
| 3026FR63A1 | 12/2025 | 1 | 07/06/2023 |
| 3031FR63A1 | 12/2025 | 1 | 12/04/2023 |
| 3047FR63A1 | 01/2026 | 1 | 29/03/2023 |
| 3053FR63A1 | 01/2026 | 1 | 12/04/2023 |
| 3060FR63A1 | 02/2026 | 1 | 24/04/2023 |
| 3061FR63A1 | 02/2026 | 1 | 27/04/2023 |
| 3061FR63A2 | 02/2026 | 1 | 27/04/2023 |
| 3068FR63A1 | 02/2026 | 1 | 24/04/2023 |
| 3082FR63A1 | 02/2026 | 1 | 30/05/2023 |
| 3081FR63A1 | 02/2026 | 1 | 30/05/2023 |
| 3096FR63A1 | 03/2026 | 1 | 05/06/2023 |
| 3096FR63B1 | 03/2026 | 1 | 05/06/2023 |
| 3102FR63A1 | 03/2026 | 1 | 05/06/2023 |
| 3103FR63A1 | 03/2026 | 1 | 05/06/2023 |
| 3108FR63A1 | 03/2026 | 1 | 07/06/2023 |
| 3110FR63A1 | 03/2026 | 1 | 03/07/2023 |
| 3131FR63A1 | 04/2026 | 1 | Not yet Distributed |
| 3123FR63A1 | 04/2026 | 1 | Not yet Distributed |
| 3172FR63A1 | 05/2026 | 1 | Not yet Distributed |
Brief description of the problem
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. In addition, the PIL is missing information relating to the concentration of Sodium Benzoate. This follows changes to the information that needs to be disclosed in product information. The impacted product, and all other batches, remain within product specification and there is no issue with product quality. To ensure that prescriptions are fulfilled and patients’ access to the product is maintained, the batches on hold awaiting distribution will be sold and have been included in this notification for information. Colgate-Palmolive (U.K.) Ltd will work to ensure that compliant products are available as soon as possible.
Details of the wording discrepancies are listed below:
Tube/Carton
| Current text | Updated text |
|---|---|
| 7. OTHER SPECIAL WARNING(S) IF NECESSARY. Do not use in adolescents and children under 16 years of age. Contains Sodium Benzoate. |
7. OTHER SPECIAL WARNING(S) IF NECESSARY Do not use in adolescents and children under 16 years of age. Contains Sodium Benzoate. Sodium Benzoate may cause local irritation. This medicine contains a flavouring with limonene, linalool, citral, geraniol, and citronellol which may cause allergic reactions. |
Product Information Leaflet
| Current text | Updated text |
|---|---|
| 2. BEFORE YOU USE DURAPHATⓇ TOOTHPASTE Important information about some of the ingredients of Duraphat® Toothpaste This toothpaste contains Sodium Benzoate. Sodium Benzoate is a mild irritant to the skin, eyes, and mucous membrane. |
2. BEFORE YOU USE DURAPHATⓇ TOOTHPASTE Important information about some of the ingredients of Duraphat® Toothpaste This medicine contains 5mg sodium benzoate in each g of toothpaste. Sodium Benzoate may cause local irritation. This medicine contains a flavouring with limonene, linalool, citral, geraniol, and citronellol which may cause allergic reactions. |
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.
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.
Further Information
For medical information enquiries or stock control enquiries please contact Colgate-Palmolive (UK) Limited on 00800 321 321 32 or https://www.colgatepalmolive.co.uk/contact-us
Recipients of this notice should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
Download document