FMD alert issued for diamorphine hydrochloride lyophilisate for solution by MHRA
Posted: 25 February 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
A defect in the 2D matrix for the expiration date of diamorphine hydrochloride lyophilisate for solution has been announced by the MHRA.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a Class 4 Falsified Medicines Directive (FMD) medicines defect information alert. The notification regards two batches of diamorphine hydrochloride BP 100mg lyophilisate for solution for injection, PL 20075/0675.
Accord Healthcare Ltd, which produces the medications, has informed the regulatory body of an issue related to the expiry date for these batches, which has not been encoded in their two-dimensional (2D) data matrix. According to the MHRA, upon FMD scanning verification and decommissioning of the product, errors such as: “Invalid barcode, missing required data elements”, “Scan failed” or “Invalid entry” will appear. Due to differences in end user programmes, systems will display a different message from the NMVS alert code – this should be expected for the batches numbered F19160 and F19161 only.
The agency says that the human readable format is correct to the batch requirements and there are no concerns related to the product quality.
Healthcare professionals have been advised to perform the usual checks for falsified medicines according to the FMD Source guidance and dispense to patients if deemed acceptable based on these checks.
Due to an inadequate supply of alternative products, the drug is not being recalled. The MHRA highlights that this issue only affects the above batches and all future batches will be corrected to avoid this error.
More information on this alert can be found here.
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Related organisations
Accord Healthcare, UK Medicines and Healthcare products Regulatory Agency (MHRA)
