The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 falsified medicine directive (FMD) medicines defect information for Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for injection.
Accord Healthcare Ltd has informed the government agency of an issue related to the expiry date for two batches of the product, which has not been encoded in 2D data matrix.
“Upon FMD scanning verification and decommissioning the product, errors such as: ‘Invalid barcode, missing required data elements’ or “Scan failed” or “Invalid entry” will appear. Due to difference in the end user systems; each system will display a different message from the NMVS Alert code, and this should be expected for these two batches only,” the MHRA statement read.
However, the human-readable format is correct to the batch requirements and there are no concerns related to the product quality.
Healthcare professionals are warned that attempts to scan to verify or to verify and decommission the FMD 2D Data Matrix code on the pack will result in an ‘Alert’ of failed scan but asked to perform the usual checks for falsified medicines according to the FMD source guidance and dispense if deemed acceptable based on these checks.
|Batch Number||Expiry Date||Pack Size|
|F19160||05/2022||1 x 5 Ampoules|
|F19161||05/2022||1 x 5 Ampoules|