Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection (Accord Healthcare Ltd)

Class 4 FMD Medicines Defect Information: Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection (Accord Healthcare Ltd)

February 17, 2020

MDR number: 048-02/20

Drug alert number: EL (20)A/09

Date issued: 17 February 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 FMD Medicines Defect Information for:

Diamorphine Hydrochloride BP 100 mg Lyophilisate for Solution for Injection (Accord Healthcare Ltd.)

Accord Healthcare Ltd has informed MHRA of an issue related to the expiry date for the above batches, 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 human readable format is correct to the batch requirements and there are no concerns related to the product quality.

Batch Number Expiry Date Pack Size
F19160 05/2022 1 x 5 Ampoules
F19161 05/2022 1 x 5 Ampoules

Advice for healthcare professionals

Attempts to scan to verify or to verify and decommission the FMD 2D Data Matrix code on the pack will result in an ‘Alert’ or a failed scan. Please perform the usual checks for falsified medicines according to the FMD Source** guidance and dispense if deemed acceptable based on these checks.

Due to inadequate supply of alternative products, the product is not being recalled. This issue only affects the batches listed above and all future batches will be corrected to avoid this error.

Full drug alert can be viewed here.

Company contacts for further information

For more information or medical information queries, please contact: Accord Medical Information Department on 01271 385257.



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