Tag Archives: Product Recall

Keys to a Successful Rapid Commercial Launch

In manufacturing, pharmaceutical companies’ drugs are produced in hopes to save patients as fast as they can.  It is a “race to the finish” pharmaceutical online stated.  Getting the drug products produced and sent out to patients as fast as possible is every manufactures goal. The third highest number of drug approvals in over twenty…
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ICU Medical, Inc. Amino Acid Injection Recall

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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Parenteral Packaging

Small volume parenteral packaging includes packaging sizes from 2 to 5 mL range and is most commonly included with local anesthetics, vaccines and other traditional injectables for patients.  Small volume parenterals are used with a luer lock or luer slip that can directly connect to syringes. 10 to 100 mL containers are typically used for…
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