Oncaspar

Due to a possible quality defect, the companies Sigma-Tau Arzneimittel GmbH and Sigma-Tau Rare Diseases S.A. have decided to recall the above mentioned batches of Oncaspar® Injection Solution.Both companies have been informed by the manufacturer of the bulk Oncaspar® Injection Solution, Sigma-Tau PharmaSource Inc, Indianapolis, of the possibility that individual containers of the above mentioned batches may have fine cracks that may lead to leakage (suspected incidence: one in 5,000 injection vials). The fine cracks present the possibility of microbial contamination of the solution, which may pose an infection risk to patients. Although only a few defective containers have been observed to date, this recall is being issued as a precautionary measure.The shipment of Oncaspar® Injection Solution of the affected lots has been stopped. Sigma-tau Arzneimittel GmbH is working at full speed to provide flawless replacements, but will likely not be able to provide them for approximately two weeks.In cases where an alternative treatment is not available and treatment with Oncaspar® Injection Solution is compellingly indicated, the above Oncaspar® Injection Solution lots should only be used on a case-by-case basis under special precautionary measures. In this case, the Oncaspar® injection vials should be visually inspected for possible leakage and, in particular, for cracks in the area of the upper vial neck below the crimp cap before use. If possible and if appropriate tools are available, the crimp cap should be removed in these individual cases to reveal hidden cracks. Only bottles that do not show any cracks or leaks should be used. As an additional safety measure, we recommend the use of bacteria-retaining filters, e.g. sterile filters made of PVDF (polyvinylidene fluoride), when using the above-mentioned batches in the infusion systems.

Further inquiry note

am-qualitaetsmangel@basg.gv.at