May 8, 2008
By:
Haydia Haniff
Baxter’s heparin products appear to have been the target of a deliberate adulteration scheme, Baxter (Deerfield, IL) CEO Robert L. Parkinson said on April 29, 2008, in testimony before the US House of Representatives’ Committee on Energy and Commerce, Subcommittee on Oversight and Investigations.
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May 8, 2008
By:
Haydia Haniff
The FDA issued a warning letter to Merck and Co. (Whitehouse Station, NJ) on April 28, citing numerous GMP violations at Merck’s vaccine production operations in West Point, PA.
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May 8, 2008
By:
Haydia Haniff
Cubist Pharmaceuticals, Inc. (Lexington, MA) informed healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. (Dublin, OH).
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Apr 22, 2008
By:
Haydia Haniff
The contamination of heparin is far more widespread, and began earlier, than first believed, FDA officials announced on April 21, 2008.
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Apr 9, 2008
By:
Haydia Haniff
American Health Packaging (AHP, Valley Forge, PA), B. Braun Medical Inc. (Irvine, CA), and Covidien (Mansfield, MA), have all announced voluntary recalls of heparin products after being notified by their supplier, Scientific Protein Laboratories LLC (SPL, Waunakee, WI), of a nationwide recall of heparin sodium USP active pharmaceutical ingredient (API) because of a heparin-like contaminant.
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Mar 19, 2008
By:
Haydia Haniff
The FDA has identified the "heparin-like" contaminant in the API of Baxter's recalled heparin products to be over-sulfated chondroitin sulfate, a commonly available, cheap chemical compound.
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Mar 14, 2008
By:
Haydia Haniff
The FDA is putting into effect a border alert for all heparin products manufactured by the Changzhou SPL plant, Baxter's supplier of heparin API. This alert would stop all heparin products produced by Changzhou SPL that are slated for entry into the US now and in the future.
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Mar 6, 2008
By:
Haydia Haniff
German authorities have received a cluster of reports of adverse reactions to heparin products that are similar to the reactions previously reported to the US FDA, causing the German authorities to initiate a recall of heparin products.
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Mar 5, 2008
By:
Haydia Haniff
The FDA has found what it is calling a "heparin-like" compound in the API of heparin that is not heparin.
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