Anapen 500mcg, 300mcg and Junior 150mcg/0.3ml solution for injection in a pre-filled syringe

(Lincoln Medical Limited) Potential problem could result in a failure to deliver any adrenaline at all in an emergency situation – class 2 action within 48 hours. (EL (12)A/20)

23 May 2012

Class 2 medicines recall

Action within 48 hours

Patient-level recall

MDR 23-04/12

Product details

Lincoln Medical Limited

Anapen 500 micrograms in 0.3ml solution for injection in a pre-filled syringe

Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe

Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe

PL 18813/0003, PL 18813/0001 and PL 18813/0002

(Adrenaline (Epinephrine) autoinjector)

Alert details

Lincoln Medical Limited is recalling all unexpired units of the above products to patient level as a precaution. This is because a potential problem with delivery time and delivery volume of the dosage following activation of the autoinjector has been identified during development work. In the worst case scenario, this could result in a failure to deliver any adrenaline at all in an emergency situation. The company has informed us that they have received no defect or ADR reports from the market which may be associated with this issue.

Recipients are requested to contact any patients who may be holding units of these products and advise them to make an appointment with their GP or clinic to discuss switching to an alternative product as soon as possible.

Pharmacists are requested to return any unexpired stock via their normal wholesaler to UDG for credit.

For medical information enquiries, please contact ‘Professional Information’ on 01748 828785.

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

MHRA distribution

Further recipients by cascade:

Regional contacts for NHS Trusts and provider units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists:  Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to Independent health care establishments
Primary care trusts (England)

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