GovWire

MDR number

MDR 105-04/24

Company name

A. Menarini Farmaceutica Internazionale Srl

Product name

Invokana 300mg tablets (Northern Ireland only), EU/1/13/884/006

SNOMED Code

24088311000001106

Active Pharmaceutical Ingredient: Canagliflozin hemihydrate

Brief description of the problem

A. Menarini Farmaceutica Internazionale Srl is recalling the above batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.

This affects Invokana 300mg (30 tablets) in Northern Ireland only.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.

Advice for patients

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by 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 theMHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact menarini@medinformation.co.uk.

For stock control enquiries please contact rmillward@menariniuk.com.

Recipients of this Medicines Recall 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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Download document

Class 3 Medicines Recall: A. Menarini Farmaceutica Internazionale Srl, Invokana 300mg tablets (Northern Ireland only), EL(24)A/13