Focusing on a targeted group of patients and trials has led to more small batch productions throughout the industry. These products are often expensive and very limited within the pharmaceutical industries. When having a limited amount of product for manufacturing, issues and rejects must be near zero. Although, product loss is unavoidable—most product loss is…
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Recall of Sodium Acetate Injection Due to the Presence of Particulate Matter
Fresenius Kabi is a global health care company that produces and specializes in medication and infusion/transfusion technology. Fresenius Kabi USA voluntarily recalled seven lots of Sodium Acetate Injection on Monday, March 7th. Various amounts of iron, sodium, silicon, chromium, aluminum and cellulose found in these injections led to seven lots being recalled. The presence of…
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Breaking Through Glass Ceiling of Pharmaceutical Packaging
The creation of intravenous solutions, has led the standard practice of using glass for packaging. Having a glass package for parenteral drugs has been tested and studied in the biopharma industry, giving reasoning to why having glass containers are currently the best solution for parenteral packaging. Although, it may seem like the “best” solution as…
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Sagent Pharmaceuticals, Inc. Issues Nationwide Recall
November 19, 2021, Sagent Pharma announces a voluntary nationwide recall of Levetiracetam Injection. Four lots of Levetiracetam was recalled due to the lack of a sterile product. Issues pertaining to container closure integrity was brought to attention when found in reserve sample vials. Sagent Pharmaceuticals did not follow USP suggested guidelines for container closure integrity—distributing…
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