Austria. The manufacturer of human albumin 20% and 25% (Haemoderivate: Immuno) has voluntarily recalled these products because the pharmacopoeial specification for aluminium (200 micrograms/L or less) for treatment of premature infants and dialysis patients cannot be guaranteed over the whole shelf life of 3 years when stored at temperatures above 8EC.
The increase in aluminium content over the shelf life period is due to the fact that the glass vial releases aluminium ions. This process is catalyzed by the residual citrate content of albumin preparations and depends on storage temperature as well as on the relation of inner glass surface to the amount of liquid. For 10 ml bottles, stability of the aluminium content below 200 micrograms/l cannot be guaranteed for the shelf life, irrespective of storage conditions.
In 50 ml and 100 ml bottles stored at temperatures below 8EC, the increase in aluminium content is sufficiently slowed down so that it does not rise beyond 200 micrograms/l within the 3-year shelf life. However, at storage temperatures exceeding 8EC (room temperature), the aluminium content may increase beyond 200 micrograms/l. According to available stability studies, this threshold value is not surpassed before 12 months of storage at these higher temperatures.
References: EU/EEA Rapid Alert - Defective Product Recall dated 22 September 1998, Pharmacovigilance Section, Federal Ministry of Labour, Health and Social Affairs, Vienna.