Particulate matter was found in an Amino Acid Injection in September. ICU Medical, Inc. voluntarily recalled one lot of Aminosyn II, 15% of 2,112 units. This is a Sulfite Free IV solution used in hospitals. The recall was enforced due to particles such as fibers, hairs and proteinaceous materials. These particles were found when ICU…
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Greenpark Compounding Pharmacy Ophthalmic Recall
Greenpark Compounding Pharmacy produced and distributed compounded products from Prescription Labs Inc. nationwide. These products are intended to be sterile and could be life-threatening if used when not sterile. FDA discovered in July/August that the conditions of Greenpark Compounding Pharmacy’s facility could be causing contamination to the compounded drugs they were manufacturing. On August 18…
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Innovation Begins with a Problem
Dr. Thomas Ingallinera from Pharmaceuticals International Inc. has a motto, “challenges frame opportunities”. This motto supports many situations within the pharmaceutical industries as well as others. When companies face issues, that is when they decide that they need to make changes and updates. This system is not always the best, because when a problem occurs,…
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What to Expect from A Remote Inspection
COVID-19 created many changes in the world today. We had to alter our daily routines, within work, home and social life. The pharmaceutical industry had to work hard in this situation by staying safe, but moving fast. Remote inspection was one of the greatest differences made during the pandemic. The pharmaceutical and healthcare industry plan…
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