Tuesday, October 19, 2010

Pill Mix Leads to Cancer Drug Recall

Cross contamination has led to the recall of a cancer drug shipped to the U.S.

According to a report written by George Miller in FiercePharma, the recalled drug is Fresenius Kabi's anastrozole, and it was made by the German company's subsidiary in India, Fresenius Kabi Oncology.

The voluntary recall involves two batches of the tablets, which are used to treat breast cancer. They were made available in the U.S. by APP Pharmaceuticals, Kabi's U.S. unit based in Schaumburg, Illinois.

The drug was made at the Indian unit's plant in Baddi. Operators found drugs other than anastrozole in some of the 1-mg anastrozole bottles, according to the Economic Times. The recall comprises 7,192 bottles, each containing 30 tablets.

The specifics of the FDA recall are:

Anastrozole tablets, 1 mg, 30 Tablets per HDPE Bottle, Rx only; NDC #63323-129-30; Product Code: 129030. Recall # D-906-2010

Lot numbers 870AF0010, Exp. date: 05/2012; Lot number: 870AF00201; Exp. date: 05/2012

Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL, by letters dated September 1, 2010. Manufacturer: Fresensius Kabi Oncology Limited (Baddi), Baddi, India. Firm initiated recall is ongoing.

Cross Contamination w/Other Products: A potential for some foreign tablets to be in bottles of anastrozole tablets 1 mg.

7,192 bottles


As more and more pharmaceutical products are outsourced from underdeveloped countries and nation's with a checkered history of regulatory control, it is important that all members of the pharmaceutical supply chain, especially the contracting entity, utilize authentication technologies to make certain of the quality of the products that make up their brand.

To read the FiercePharma post, visit: http://www.fiercepharmamanufacturing.com/story/pill-mix-leads-cancer-drug-recall/2010-10-13#ixzz12RCjXsX9

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamesystems.net/.

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