China NMPA Product Recall - Freeze-dried human rabies vaccine (Vero cells)

On May 23, 2010, the Wuhan Institute of Biological Products initiated a voluntary recall for a specific batch of its "Freeze-Dried Human Rabies Vaccine (Vero Cell)," identified as batch number 200905007-3. The decision to recall was made after it was discovered that the bacterial endotoxin levels in this batch surpassed acceptable safety limits. These endotoxins, derived from Gram-negative bacteria, are known to cause transient fevers if present in excessive concentrations. To manage the recall and safeguard public health, the company established a dedicated department. The Hubei Provincial Food and Drug Administration confirmed that 10,902 doses of the affected vaccine had been distributed. By May 24, 2,526 unused doses were successfully retrieved or secured. Importantly, no adverse reactions were reported from the 8,376 doses that had already been administered. This recall was conducted under the