Meningococcal vax recalled worldwide
A review of all batches manufactured since October 2012 was prompted by two European reports of particulate matter in the single-dose prefilled syringe.
Emerge Health, the manufacturer of Meningitec (which is sponsored by Pfizer), said the contaminated material originated from manufacturing equipment.
In a recall alert issued this morning, the TGA said the risk that an individual in Australia had received a contaminated dose of vaccine was very low because only a small number of doses per batch were affected by the contamination.
According to estimates provided to the TGA by the sponsor, the amount of iron oxide found in a contaminated syringe could be up to a maximum of 105mg, with an estimated elemental iron amount of about 70%.
This amount of iron oxide would be readily visible during a pre-vaccination visual inspection of the vial, which doctors are advised to do routinely as specified in the Australian Immunisation Handbook.