Insulin pens recalled: fears of hyperglycaemia
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 |