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Important customer notice Medical Device Alert

Emollients MHRA Drug Safety Update

Ref:2018/572

ICN number:572

  • Date:09/01/2019
  • Product area:Wound Care | Miscellaneous |

Change:

  • The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update, regarding the warning about the risk of severe or fatal burns with paraffin-containing and paraffin-free emollients.

Impact:

  • The warning previously communicated in January 2008 referred to emollients containing more than 50% paraffins. Evaluation of recently available data showed that products containing less than 50% paraffin and paraffin-free emollient residue allowed to build up on fabric, also have a fire accelerant effect.
  • There are 12 NHS Supply Chain products affected. The catalogue description of these products has been amended to reflect this update.
  • Please refer to the product listing below for full details.

Next Steps:

  • Read the attached report, MHRA Drug Safety Update, volume 12, issue 5, December 2018:3.
  • Customers are advised to read page nine which details advice for healthcare professionals and the recommendations of the Commission on Human Medicines (CHM).
  • Please note this is the only notification in issue five which affects products available via NHS Supply Chain.
  • For further information please contact your local Customer Service Advisor.

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572 Drug Safety Update December 2018

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572 Emollients Product Listing

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Should you require further information about this contract, including pricing and how to order the products, please contact your NHS Supply Chain account manager using the link below.

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