Pharmaceuticals Recalled Due to Metallic Contaminants
EMSL Analytical provides materials testing and forensic analysis to determine foreign substances in pharmaceuticals, food products and other manufactured goods.
This month a manufacturer of an intravenous blood pressure medication announced a voluntary recall of their product because of the potential presence of foreign matter. The material, according to reports, is made up of sub visible inert stainless steel particulates of approximately 2.5 microns in diameter.
Contaminated pharmaceuticals are not a new phenomenon. In the past there have been numerous cases of contamination from viruses, fungi, bacteria and foreign substances. Perhaps one of the most striking cases was the estimated 6,000 to 10,000 hemophiliacs who became infected with the HIV virus from contaminated blood products in the late 1970s and early 1980s.
More common cases of adulterated products come from cases such as the recalled blood pressure medication. During the production of pharmaceuticals a host of machinery is involved that can begin to wear and allow metallic, or other, particulate matter to enter the product during the manufacturing process.
For these cases the characterization of these materials may be the single most important step in understanding where and how the contamination entered the manufacturing process. The Materials Science Division at EMSL Analytical, with its cutting edge instrumentation along with their renowned scientists is always available to help clients develop solutions to challenges in manufacturing, quality assurance, and research and development. The laboratory applies a full spectrum of standard and customized analyses, elemental and chemical, structural, particle, surface, contaminant, mechanical, failure and bio-effectiveness to projects.
EMSL provides materials testing, characterization, and forensic laboratory services for a wide range of pharmaceutical, food processing, manufacturing, regulatory and law enforcement customers. Solutions and answers on a variety of projects are just a phone call away.
“EMSL has a long history of working with pharmaceutical and consumer goods manufacturers to ensure final products meet all necessary requirements,” reported Joe Frasca, Senior Vice President at EMSL. To learn more about materials testing please visit www.EMSL.com, call (800)220-3675 or email info@EMSL.com.
About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of food, environmental and materials testing services and products to professionals and the general public. The company has an extensive list of accreditations from leading organizations as well as state and federal regulating bodies.
- Contact Information
- Joe Frasca
- Senior Vice President, Marketing
- EMSL Analytical, Inc.
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