Field Safety Notice Reflex Table Top Sweetener Tablet (ICN 1889)

MHRA NA

NHSSC : 66

Alert:

• The supplier Nutshell Portions has provided a field safety notice withdrawing one batch of the reflex sweetener tablet following the amendment of EU regulation 231/2012 (specification for food additives) to regulation 1396/2022, on 1 September 2022, which set a reduced maximum limit of 0.1mg/kg for all food additives.
• Nutshell advise the raw material in the reflex table top sweetener tablet contains Ethylene Oxide at levels >0.1mg/kg.
• Due to the amount of this raw material used in the formulation of the reflex sweetener tablets and taking into account normal conditions of use (6-9 tablets per person, per day) we are advised the exposure margin is considered to be minimal.

Products Affected:

• There are no other product codes affected.
• Please note NHS Supply Chain has checked current stocks of this product and future deliveries will be of unaffected batch numbers.

Next Steps:

• Please read and follow the full instructions in the field safety notice and share with all users of the affected product.
• To cease use and contact your local NHS Supply Chain Customer Service Advisor with full details of affected products in your possession. You will be given a unique CMS reference and advised to dispose of the goods in accordance with your local regulations.
• On receipt of written confirmation of disposal, quoting your unique reference number full credit will be given.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.