Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07)

Caution in Use: Distribute to Pharmacy and Clinic Level.

From:
Medicines and Healthcare products Regulatory Agency
Published
18 April 2018
Message type:
Medicines recall/notification
Medical specialty:
Anaesthetics, Cardiology, Care home staff, Cosmetic surgery, Critical care, Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, Vascular and cardiac surgery
Issued:
18 April 2018

Product information

MDR number

MDR 049-12/17

Company name

Techdow Europe AB

Product description

Inhixa solution for injection in pre-filled syringe 2,000 IU (20 mg) in 0.2 mL; 4,000 IU (40 mg) in 0.4 mL; 6,000 IU (60 mg) in 0.6 mL; 8,000 IU (80 mg) in 0.8 mL; 10,000 IU (100 mg) in 1.0 mL.

Marketing Authorisation number

  • EU/1/16/1132/012
  • EU/1/16/1132/014
  • EU/1/16/1132/016
  • EU/1/16/1132/018
  • EU/1/16/1132/020

Brief description of the problem

Techdow Europe AB has issued the Direct Healthcare Professional Communication (DHCP) attached due to rare cases of premature self-activation of the safety device in unused, unopened pre-filled Inhixa syringes as shown in the DHCP diagrams. When premature activation has occurred, administration is not possible.

Advice for healthcare professionals

To minimise the risk of missed doses:

  • Pharmacists should visually check all Inhixa syringes before dispensing to check if they are affected by the self-activation defect as shown in the DHCP diagrams. Do not open the syringe blisters.
  • Individual syringes that are affected by the self-activation defect should not be dispensed to patients.
  • Pharmacists should make sure they have sufficient stock of Inhixa available as replacements.

Company contact information

Techdow Pharma England Limited can be contacted on 01271 334 609.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to community pharmacists, hospital pharmacists, relevant clinics and dispensing general practitioners (GPs). It is not necessary to forward this notice to non-dispensing GPs.

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Class 4 medicines defect information: Inhixa solution for injection in pre-filled syringe (EL (18)A/07).

Published 18 April 2018

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