CSL safety review may affect human albumin supply
The TGA has temporarily quarantined all stocks of human albumin, after CSL informed the regulator on Wednesday that “some batches” of the product processed up to 25 January were contaminated.
The new contamination issue follows scrutiny of CSL’s vaccine manufacturing process in the wake of adverse events linked to its paediatric influenza vaccine in 2010.
Affected batches were found to contain “very low” levels of ethylene glycol, traced to a fault in the lining of a tank used in its manufacture.
Exposure to the chemical poses the risk of kidney damage or acute renal failure in patients.
“TGA has put arrangements in place to quarantine stocks held by hospitals, the Australian Red Cross Blood Service… and CSL from further use or issue until safety implications have been fully assessed,” the TGA said in a statement.
“As a result of this action by TGA, supplies of