Medicine Supply Notification: Metformin 500mg/5ml oral solution

Department of Health and Social Care (DHSC) has issued a Medicine Supply Notification (MSN) for Metformin 500mg/5ml oral solution

MSN/2021/045

Tier 2 – medium impact

Date of issue: 13/09/2021

• Advanz Pharma have discontinued metformin 500mg/5ml oral solution due to further testing requirements necessitated by the potential presence of N-nitrosodiethylamine (NDMA) impurities
• Rosemont Pharmaceuticals have recalled one batch of metformin 500mg/5ml oral solution due to the presence of NDMA impurities and are therefore out of stock due to further testing requirements
• Limited supplies of metformin 500mg/5ml oral solution are expected to be made available week commencing 4th Oct 2021, however, this is unable to support full demand.
• Long term supply issues of metformin 500mg/5ml oral solution are expected.
• Metformin 850mg/5ml and 1000mg/5ml oral solutions remain available but cannot support an increased demand.
• Metformin 500mg powder for oral solution sugar free is available but cannot fully support an uplift in potential demand
• Supplies of metformin 500mg/5ml oral solution specials can be sourced. However, the presence of NDMA within Specials is unknown. Therefore, it is imperative that Specials are only prescribed where all other options have been exhausted.

The following specialist importers have currently confirmed they can source unlicensed metformin 500mg/5ml oral
solution (please note, there may be other companies that can also source supplies):

• Ascot Labs
• Eaststone Specials
• Nova Laboratories
• Quantum Pharmaceuticals
• Target Healthcare
• Thame Laboratories

If there is currently no listing on dm+d for the imported product for prescribers to select using their prescribing systems an EPS prescription for unlicensed metformin 500mg/5ml oral solution cannot be issued. Where a prescriber wishes to prescribe an unlicensed import, an FP10 paper prescription should be issued as ‘Metformin 500mg/5ml oral solution (Special Order)‘ and endorsed by the pharmacy as a non-Part VIIIB special with the following information:

• Amount dispensed over pack size used;
• Invoice price per pack size from which the order was supplied less any discount or rebate;
• Manufacturers’/importers’ MHRA licence number;
• Batch number of the product supplied;
• SP

The DHSC Medicine Supply Team provide a monthly update on potential supply issues affecting both primary and secondary care. This update is uploaded on the Specialist Pharmacy Services (SPS) website. To register, you will need  an NHS email address. Once set up and logged in, you will be able to access it online.

New shortages not listed on the SPS website, can be reported using our shortage reporting tool.