Articles by Haydia Haniff - BioPharm International

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Articles by Haydia Haniff

Merck Receives Warning Letter for Vaccine Operations

May 8, 2008

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.

Leached Impurity Found in Cubicin Stored in Cardinal Health’s ReadyMED Pumps

May 8, 2008

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).

Heparin Products the Target of Deliberate Adulteration, Says Baxter CEO

May 8, 2008

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.

Heparin Contamination More Widespread than First Thought

Apr 22, 2008

The contamination of heparin is far more widespread, and began earlier, than first believed, FDA officials announced on April 21, 2008.

Three Companies Recall Heparin Products Because of Contaminant

Apr 9, 2008

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.

Heparin Contaminant Identified by FDA

Mar 19, 2008

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.

FDA Issues Border Alert for All Heparin Products

Mar 14, 2008

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.

German Ministry of Health Recalls Heparin Products

Mar 6, 2008

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.

FDA Finds "Heparin-like" Contaminant in Heparin API

Mar 5, 2008

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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