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Insulin pens recalled: fears of hyperglycaemia

MHRA: Patients should check the code printed on their Owen Mumford insulin pen

The dose selector on certain batches of Owen Mumford's Autopen can suddenly revert to zero, medicine regulator the MHRA warns

A manufacturer has recalled faulty batches of insulin pens over concerns they could cause patients to develop hyperglycaemia, the MHRA has said.

 

The dose selector on batches of four models of the Autopen, manufactured by Owen Mumford, could “suddenly” revert to zero, the MHRA warned. This could result in patients receiving a smaller dose of insulin than intended or none at all, the medicines watchdog said yesterday (December 17).

 

The failure rate of the 4,290 pens from the affected batches that had already been distributed in the UK was 42 per cent, the MHRA said. Patients should check the three-letter code printed on the lower part of the pen’s body or on the outer carton of its packaging to see if it was from one of the faulty batches, it stressed.


Pharmacists should quarantine the affected pens and return the stock to Owen Mumford on 01993 812 021 or [email protected], the MHRA added.


It was also “vital” that affected patients sought a replacement “at the earliest opportunity” by visiting their pharmacist or contacting Owen Mumford, said MHRA clinical director of devices Neil McGuire.

 

Affected batches are:

Packaging lot code

Product code

Product name

7VJ

AN3810

3ml 1 Unit Autopen Classic

7WB

AN4200

Autopen 24 3ml 2 Unit

7WC

AN4210

Autopen 24 3ml 1 Unit

7WD

AN3800

3ml 2 Unit Autopen Classic

8CN

AN4200

Autopen 24 3ml 2 Unit

8CP

AN4200

Autopen 24 3ml 2 Unit

8CR

AN4210

Autopen 24 3ml 1 Unit

8EL

AN3800

3ml 2 Unit Autopen Classic

8EM

AN3810

3ml 1 Unit Autopen Classic

8JK

AN4210

Autopen 24 3ml 1 Unit

8JM

AN3800

3ml 2 Unit Autopen Classic

8JN

AN3810

3ml 1 Unit Autopen Classic

8JP

AN4210

Autopen 24 3ml 1 Unit

8VV

AN4200

Autopen 24 3ml 2 Unit

8VW

AN4200

Autopen 24 3ml 1 Unit

 

Production lot code(stamped on pen)

Product code

Product name

7RT

AN3810

3ml 1 Unit Autopen Classic

7PN

AN4200

Autopen 24 3ml 2 Unit

7PP

AN4210

Autopen 24 3ml 1 Unit

7RV

AN3800

3ml 2 Unit Autopen Classic

8KK

AN3800

3ml 2 Unit Autopen Classic

8XD

AN4200

Autopen 24 3ml 2 Unit

 

3 Comments

Alia Arif, Locum pharmacist

How quickly will Hub and Spoke pharmacies be able to action Medicine/Device recalls when they are serving their millions of patients?

Chris Howland-Harris, Community pharmacist

According to customer services at Owen Mumford, these batches were issued between April and September 2014, so anything issued to patients before April this year will not be affected.

N O, Pharmaceutical Adviser

So any hospital admission of patients using these pens between April and NOW are due to the faulty pens ??? So will the company bear all the costs ??? Will there be any criminal investigation against the company ??? Oh sorry, these things happen only when a Pharmacist makes the error not a Company !!!

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