Sanofi Pasteur is one of the top vaccine maker companies with global sales totaling in $6 billion annually. Their plant in Monroe County, Pennslyvania, found shards of glass in their ActHIB vaccine created for babies. According to the FDA, this vaccine prevents a type b Haemophilus influenzae. The batches the glass were found in this vaccine, but it was still distributed in April of 2013. The medication expired in September 2014.
Sanofi Pasteur sent their drug samples for analysis and delamination was found, which happens when glass is found in vaccines. The effects of delamination are not dangerous and according to The Morning Call, no one has suffered from Sanofi Pasteur's vaccines because of this.
However, the FDA does warn against contaminated vaccines with glass explaining that they can be very dangerous. The Sanofi Pasteur went against the FDA's warnings and promoted their product as safe. Babies were injected with the glass contaminated ActHIB vaccine for a year and a half.
Word eventually got to the Sanofi Pasteur headquarters about the contaminated vaccines and that led to an FDA investigation. The FDA composed a 44-page report about the safety precautions Sanofi Pasteur failed to take when creating their vaccine.
The FDA concluded, however; that the glass found in the vaccine was harmless and that is why there was no recall. In 2015, Sanofi Pasteur again found glass and now stainless steel in their ActHIB vaccine. This time the company reported the problem to the FDA.
No problems have been reported from the use of the ActHIB vaccine. However, several doctors and parents were angry with Sanofi Pasteur because they trusted the company to provide them with safe products.
A spokesperson for Sanofi Pasteur claims the company did not recall the vaccine because they knew it was safe. The representative stated, "Above all else, we want the public to understand and have faith that we are dedicated to providing them with vaccines that are safe and effective in protecting them against vaccine-preventable disease."
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