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FMD recall issued for the first time in six months

Batch K84X of the Beconase Aqueous Nasal Spray from GSK has been recalled
Batch K84X of the Beconase Aqueous Nasal Spray from GSK has been recalled

A falsified medicines directive (FMD) recall has been issued for GlaxoSmithKline’s (GSK) Beconase Aqueous Nasal Spray – the first alert of its kind since July 2019.

Healthcare professionals and wholesalers have been told to immediately stop supplying batch K84X of the Beconase Aqueous Nasal Spray from manufacturer GSK.

This is due to an “issue related to error in the decommissioning” in the stated batch, the Medicines and Healthcare products Regulatory Agency (MHRA) said in the alert issued yesterday (February 12).

Any remaining stock should be quarantined and returned to suppliers, according to the recall notice. The Pharmaceutical Services Negotiating Committee (PSNC) has confirmed to C+D that the alert applies to community pharmacies.

FMD a year on

It is the first alert issued under the EU’s anti-counterfeit legislation since July 25 last year.

FMD is an EU medicines scanning law that came into force last February, with the aim of preventing counterfeit medicines from entering the drugs supply chain.

However, in the months after the legislation was implemented, there were reports of false alerts and a delay in pharmacies purchasing the necessary equipment to become FMD-compliant.

The future of FMD in the UK following its exit from the European Union has not yet been confirmed.

11 Comments
Question: 
Does your pharmacy stock the Beconase Aqueous Nasal Spray batch the recall applies to?

Chris Pharmacist, Community pharmacist

Let me get this right. The Beconase nasal sprays have to be quarantined for destruction because GSK have mistakenly marked the packs as destroyed...a complete waste of time, money and effective medicines.

...no wonder FMD isn't being taken seriously any more. Another Brexit bonus (I can already hear the boos)

Reeyah H, Community pharmacist

So basically, stock with nothing wrong with it is being recalled due to the whole FMD nonsense at the start of the chain.  

Dave Downham, Manager

Not quite the "if we don't do FMD, the UK will become the dumping ground for fraudulent medicines" that we were warned about then?

Uma Patel, Community pharmacist

MHRA should be open and transparent to have any credibility

 

I still can't believe community pharmacies have received no funding related to FMD set up and ongoing costs (actually I can believe it). Dispensing doctors don't bother with it at the moment.

When EPS came in we got a payment (£200 I think), I know it's not big money but you'd think funding would be negociated then the service brought in, not the other way round.

A.S. Singh, Community pharmacist

One year on does anyone see a point in this?

Leon The Apothecary, Student

None here in my opinion. The only benefit I have had with it is that it's a date checking device and depending on the software an additional layer of accuracy checking.

Uma Patel, Community pharmacist

Can we have a proper explanation

David Moore, Locum pharmacist

an “issue related to error in the decommissioning”

Could we have that in English, please?

Oliver Staunton, Information Technology

After reading the MHRA alert at https://www.pharmdata.co.uk/mhra_alert.php?id=0b7e64717e3d0f0e35abf92d352e52ce it looks like the manufacturer may have accidentally marked all the packs as having been destroyed, on the European repository. This would lead to FMD alerts when pharmacies tried to scan/decommission them, so the affected batch is being recalled instead.

Margaret O'doherty, Community pharmacist

So if you get a message saying it has been destroyed instead of looking at it and believing your eyes that it is  intact and clearly not destroyed you should quarantine it and make more work for yourself.

 FMD still hasn't done anything for patient safety. What a farce.

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