Drug Company Fails to Issue Recall for Vaccines with Broken Glass

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One of the world’s leading vaccine manufacturers, Sanofi Pasteur, discovered tiny pieces of glass in certain batches of a vaccine intended for babies. The glass was detected in April 2013 in samples of a vaccine that was already distributed to customers. The vaccines were sent to an outside laboratory for analysis, and that lab found evidence of delamination. Delamination occurs when vaccine vials shed flakes of glass called lamellae.

The FDA warned that lamellae could cause serious health problems, such as an adverse immune system reaction. In most cases when lamellae contaminate a drug, medical manufacturers recall the products. In this case, however, the vaccine maker allowed the vaccine to continue to be used for another year and a half. The FDA found out about the issue and did not push back.

This contamination issue, which occurred in 2013 and 2014, has been kept quiet until now. The company claims that the vaccines met the applicable requirements for safety, and the FDA did not issue a recall. Experts are now pushing back against the company’s actions and the FDA’s response. Two months passed between when the drug company discovered the problem and when it was reported to the FDA, and another 11 months passed before the FDA did an inspection.

Sanofi Pasteur earned $43 billion in 2014, placing it as the fifth largest pharmaceutical company in the world. It ranks second among vaccine makers. Unfortunately, drug companies often are more concerned with profits than with keeping the public safe. When a person is harmed because of a dangerous prescription drug, that individual has the right to compensation through a lawsuit. If you have been harmed by a dangerous drug, call the Houston prescription drug recall attorneys at Kennedy Hodges at 855-947-0707. We can help. Call us today to learn more, or visit our YouTube channel to learn more. 

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