Over 100 million Moderna shots have been administered to patients and just recently, Moderna reached out to the FDA for their full approval. Tuesday, June 1st, Moderna asked the FDA for a full approval of their COVID-19 Vaccine—the second drug producer in the U.S. to seek a biologics license that will allow it to market…
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Hospira Issues A Voluntary Nationwide Recall
On May 4th, 2021, Hospira—a Pfizer company, issued a voluntary nationwide recall to lot DN9185 for potential presence of visible particles. This drug product is a sterile water for injectables and is used to dilute or dissolve drugs for injection. Risks to patients are rare, but could potentially conclude anaphylaxis, fever, gastrointestinal disturbances, vein irritation,…
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Testing Container Closures
During the manufacturing process of injectable drugs, all pieces and parts need to go through a visual inspection process. The container, closure, product and final product all need to have individual inspections. Container closure integrity is extremely important, especially when involved with parenteral drugs. Parenteral drugs have the highest risk packaging application concern for closure…
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Johnson & Johnson Covid-19 Vaccine Recall
15 million Johnson & Johnson vaccines ruined from a manufacturer in Baltimore. These vaccines were scheduled to be delivered within the next month; but quality control is now being questioned. At the manufacturer—Emergent BioSolutions, they mixed up the ingredients for the J&J single-dose vaccine with a different COVID-19 vaccine that was being produced in the…
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