Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - misalignment of the syringe label

(Aurum Pharmaceuticals Limited (trading as Martindale Pharma)) Replaces drug alert issued on 29 April 2013 (EL 13(A)13 Rev 1)

07 May 2013

Class 4 medicines defect information

Caution in use

Distribute to pharmacy level

MDR 62-03/13

Product details

Aurum Pharmaceuticals Limited (trading as Martindale Pharma)

Adrenaline 1mg/10ml solution for injection in a pre-filled syringe PL 12064/0006

Amiodarone 30mg/ml solution for injection in a pre-filled syringe PL 12064/0047

Ephedrine Hydrochloride 3mg/ml solution for injection in a pre-filled syringe PL 12064/0043

Alert details

Product name   Batch number range from and to inclusive   Expiry date range From and to inclusive   First distributed
Adrenaline 1mg/10ml   From 5000879 to 5000964   From 05/2014 to 07/2014   06 Feb 2013
Amiodarone 30mg/ml   From 5000610 to 5000870   From 02/2014 to 11/2014   28 Nov 2012
Ephedrine Hydrochloride 3mg/ml   From 5000377 to 5000846   From 06/2013 to 10/2014   27 Oct 2011

Please replace the drug alert issued on 29 April 2013 with this revised document. Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed us that a batch number was missed in the original alert. The table, above, has now been corrected. The company apologises for any additional inconvenience this may cause.

Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed us that there is a misalignment of the syringe label of the above pre-filled syringe batches. The syringe label includes the graduated volume markings.

Pre-filled syringes from the affected batches should be used with caution.

Class 4 Drug Alert (Caution in Use): Aurum Pharmaceuticals Limited (trading as Martindale Pharma) - Adrenaline (Epinephrine) Injection, Amiodarone Injection, Ephedrine Hydrochloride Injection - EL 13(A)13

The syringe in the top position has the label in the correct position.

The syringe in the lower position has the label applied too close to the end of the barrel and should be used with caution.

The implication of this misalignment is that incorrect dosing could occur if the entire contents of the syringe are not used. For example if a dose was titrated between the intermediate and completely empty position.

The fill-volume and total dose in the syringe is correct. It may appear that there is over-fill of the syringe. Do not discard what appears to be excess before administration.

This issue has been corrected by the manufacturer however this issue may be present within the market for a period of time.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

Download documents

Help us improve GOV.UK

Don’t include personal or financial information, eg your National Insurance number or credit card details.