Packaging issue potentially impacting the sterility of needle softpacks of Infanrix Hexa.

Infanrix hexa [diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)]: Packaging issue potentially impacting the sterility of needle softpacks of Infanrix Hexa.

Summary

• A packaging issue potentially impacting the sterility of needle softpacks provided with pediatric vaccine Infanrix hexa. 
• Neither the syringe nor its content are impacted by this packaging defect.
• In scope of the packaging issue are needles supplied with the 10x dose presentation pack of Infanrix hexa (10 vials + 10 pre-filled syringes + 20 needles). 
• The identified defect is a minor hole with a diameter of 1 mm, found on the paper section of the needle softpack.
• This hole could compromise the sterility of the enclosed needle. Because the defect is not easily detectable, and as a precautionary measure, GSK recommends that the Healthcare Professionals to:
  • Discard the needle packs from all the boxes of the affected batches to exclude any potential safety issues for patients
  • Use other available needles for vaccine administration, of the same gauge and length as the discarded ones
  • Share the information with relevant healthcare personnel under your supervision