Heparin - What APP is doing to meet customer needsSubsequent to a January 17, 2008 recall of 9 lots of Baxter Healthcare Corporate (Baxter) 1000U/mL, 10 and 30mL MDV Heparin products, Baxter recalled all multi- and single-dose vials of Heparin as well as their Heparin flush products on February 28, 2008 as a result of an increase in reported serious adverse effects including death. Baxter’s manufacturing of Heparin was stopped as the U.S. Food and Drug Administration (FDA) worked with Baxter to determine the cause. In close collaboration with the FDA and their Drug Shortage team, APP stepped in and dramatically increased its manufacturing capacity for Heparin to assure healthcare professionals that it would take every step necessary to meet supply needs for the U.S. market of this life-saving drug. Today, APP has more than doubled its manufacturing of Heparin to not only address current demand, but to begin the process of restocking the pipeline of drug. In addition to APPs testing procedures, APP has implemented the new FDA raw material testing and is proactively advancing its testing procedures to assure customers and the patients they treat that drugs provided by APP, such as Heparin, are safe because they are manufactured with unprecedented quality and integrity throughout all stages of the manufacturing process. - New Heparin Labeling Information (5/23/08) - Heparin Product and Competitor Recall Fact Sheet (4/15/08)
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