Medicines Healthcare Products Regulatory Agency
MDR number
MDR 053-04/23
Company name
Tricodent Limited (supplier)
Product name
Medical Oxygen B.P (MEDIGAS OXYGEN B.P), PL 04280/0001
Active Pharmaceutical Ingredient: oxygen
Brief description of the problem
The Medicines and Healthcare products Regulatory Authority (MHRA) has been made aware that falsified medical oxygen has been provided to several dental practices across the UK. You may have received an email from the Care Quality Commission alerting you to this issue. The source of the supply has been identified as batches provided by Tricodent Limited. An assessment of risk to public health and patient safety has been completed and the risk was found to be low. A criminal investigation into the company that supplied this stock is ongoing. The falsified product in circulation is labelled: Medical Oxygen B.P PL No 04280/0001 MEDIGAS OXYGEN.
We urge you to check your oxygen supplies and ensure you have not been supplied with this product. If you find evidence that any of your oxygen is labelled as shown above, stop using it and replace it with legitimate stock. If you have been supplied with this product, please notify MHRA Senior Criminal Enforcement Officer Mark Ling via email. All healthcare professionals must ensure that medical oxygen supplies are procured only from authorised and licensed manufacturers or from authorised wholesale dealers of medical oxygen. It is vital that you check that your practice suppliers are authorised and licensed by the MHRA. Your supplier should have a Wholesale Dealers Authority, which is supplied by the MHRA.
Advice for healthcare professionals
Stop using the product immediately and quarantine all remaining stock. Authorised and licensed suppliers can offer advice regarding disposal of falsified cylinders, do not return cylinders to Tricodent Limited.
Advice for patients
No further action is required by patients as this is a specific recall for medical oxygen, primarily used by dental practices. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.
As for all medicines, 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
Authorised and licensed suppliers can offer advice regarding disposal of falsified cylinders, do not return cylinders to Tricodent Limited. For further information on this issue from the MHRA, please contact MHRA Senior Criminal Enforcement Officer Mark Ling: Mark.Ling@mhra.gov.uk
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to dental practices, 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