Particles continue to cause major compliance problems and recalls

Again, a batch of sterile products has been recalled due to detected particles. In this case, the company Hospira has initiated a recall of the medicinal product "Labetalol Hydrochloride". Labetalol Hydrochloride a clear colourless solution for intravenous administration used in cases of severe blood pressure. The recall action concerns a lot with 20 mL multidose glass vials. The reason for that recall is "embedded particulate within the glass vial and visible particles floating in the solution". Investigations could identify the embedded particulate as stainless steal and the particles in the solution as iron oxide. The problems with the embedded particulate have been attributed to a supplier's glass defect. Because of the size of the particulates, "it is likely that particulates are able to pass through the catheter and may cause injection site reactions and local irritation in the blood vessels, tissues and organs".

Actual health damages by the lot concerned aren't known.

You can find the report on the voluntary lot recall on the FDA website.

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