Germany. The Paul-Ehrlich-Institut has recalled certain batches of human albumin products (Human Albumin 20%, Human Albumin 20% Immuno, Human Albumin Immuno 20%, Human Albumin 25% Immuno) with effect from 30 September 1998, including batches that have exceeded 12 months of shelf-life.
This action was taken after quality assurance tests showed that the aluminium content of these batches had exceeded the maximum level of 200 micrograms/L. This could result in adverse effects especially in neonates and dialysis patients because of deposits in the brain and bones.
Similar actions have been taken in Belgium and Italy.
[See also Pharmaceuticals Newsletter Nos. 9 & 10, September & October 1998]
Reference: Pharmazeutisches Zeitung 143(43): 3746 (1998).