Australia's CSL Withdraws Seasonal Trivalent Flu Vaccine For Children Under 5
This article was originally published in PharmAsia News
Executive Summary
PERTH, Australia - Australia's CSL Biotherapies has ceased distribution of its pediatric seasonal influenza vaccine following a significant increase in reports of fever and febrile convulsions in children under 5 years of age shortly after receiving CSL's Fluvax Junior vaccine compared to previous seasons, CSL announced June 1
You may also be interested in...
FDA Warning Letters Hit Inadequate Investigations and QC Failings
In recent warning letters, FDA continued to hammer manufacturers for inadequate investigation of out-of-specification results and lax oversight of manufacturing operations by quality control units.
FDA Warning Letters Hit Inadequate Investigations and QC Failings
In recent warning letters, FDA continued to hammer manufacturers for inadequate investigation of out-of-specification results and lax oversight of manufacturing operations by quality control units.
Australia's CSL Slapped With U.S. FDA Warning Letter Over Flu Vaccine
U.S. FDA's Center for Biologics Evaluation and Research slapped CSL Biotherapies with a warning letter June 15 for significant objectionable conditions related to current good manufacturing practices at its Victoria, Australia, manufacturing plant