Voluntary Precautionary Recall of Diprospan
January 28, 2023 12:30 pm
Today, the Department of Health (DH) endorsed Organon to conduct a voluntary recall of U037539, W001030, W026080 & W032423 of batches of Diprospan out of an abundance of caution due to use of a stainless-steel component in the manufacturing assembly that has the potential for corrosion, which could result in particulates within the injection vials. All batches of the product have been inspected for quality in accordance with Organon’s practices and industry standards. In the unlikely event that patients are exposed to the stainless-steel particles, there is a low likelihood of harm to patients when used as indicated on the label.
No product quality complaints have been reported related to the presence of stainless-steel particles within distributed product batches. Moreover, there have been no reported adverse events attributable to particulate matter in the potentially impacted and distributed product batches. We are actively working to identify near- and long- term solutions to replenish supply.
If you have a question about this voluntary recall, please contact Organon Hong Kong DPOC at 852-3427-8171.