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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Is Your Sterile Injectable Ready for Changes in Raw Materials?
In any manufacturing company, it is likely that raw material will change from time to time. These changes are modifications in API synthesis, key starter materials and intermediates. These changes are expected and necessary for manufacturing improvement. The best approach to alternating materials from a supplier, is to always keep track and maintain data and…
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Is your Equipment Qualified?
The slightest error or misuse of equipment could lead to an expensive risk, delay manufacturing of a product and minimize the amount of sales. It is necessary to have all items involved in the manufacturing process go through a qualification test. Equipment qualification is extremely critical. Qualification needs to be documented and recorded for both…
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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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