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26 Mar 12

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Recalls Threaten Public Confidence in Vaccines and Immunoglobulins

Quality defects and donor tissue history must be more carefully monitored to increase public acceptance if the biologics market is to succeed, according to a new report by business intelligence experts GBI Research.

The new report* refers to the emerging pattern emerging in drug recalls over recent years, which shows that vaccines and immunoglobulins, in particular, have failed to meet safety standards. Biologics are drugs that contain an active substance produced by or extracted from a biological living source, which can include humans, animals, cells or microorganisms. Biological products and biologics have definite risks, as they are often only partially understood at the time of approval, with a highly complex production and purification process.

Products extracted from human blood or plasma also carry the risk of contamination with pathogens from the donor. Biomedical Tissue Services (BTS) recalled human tissue in October 2005 after the company discovered that tissue may have been procured from donors without properly evaluated medical and social histories. This prompted companies such as Regeneration Technologies, Inc. and Tutogen Medical, Inc. to also recall human tissue products.

These recalls not only interrupt medical progress, but damage patient compliance rates, as fears develop over the safety of treatments. Immunoglobulins and vaccines were found to be the drug classes most prone to recalls during 2007–2010. Throughout this time, 14 recalls for vaccines and 13 recalls for immunoglobulins were recorded, due to a combination of serious adverse events, labeling errors and manufacturing defects. The majority of errors that occurred throughout 2004–2010 were due to quality defects, such as reduced levels of potency and even the presence of glass particles.

Analysis of biologics recalls during 2004-2010 revealed that treatments for infectious, immunodeficiency and cardiovascular diseases consistently appeared in lists of recalled products. These three overarching disease types account for a major percentage of medical revenue worldwide, and the improvement of biologics safety profiles could open up lucrative opportunities for pharmaceutical companies in the future.



This report provides in-depth analysis of biologics recalls issued or reported with the US Food and Drug Administration (FDA) and its constituent agencies. It analyzes biologics recalls on the basis of the reason for recall, therapy area, drug class, dosage forms and the recalling company, on a year-to-year basis throughout 2007–2010. The report is built on data and information sourced from the FDA database of biologics recalls and in-house analysis conducted by GBI Research’s team of industry experts.


GBI Research is a market-leading provider of business intelligence reports,offering actionable data and forecasts based on the insights of key industry leaders to ensure you stayup-to-date with the latest emerging trends in your markets.

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