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:
PRODUCT
Anastrozole tablets, 1 mg, 30 Tablets per HDPE Bottle, Rx only; NDC #63323-129-30; Product Code: 129030. Recall # D-906-2010
CODE
Lot numbers 870AF0010, Exp. date: 05/2012; Lot number: 870AF00201; Exp. date: 05/2012
RECALLING FIRM/MANUFACTURER
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.
REASON
Cross Contamination w/Other Products: A potential for some foreign tablets to be in bottles of anastrozole tablets 1 mg.
VOLUME OF PRODUCT IN COMMERCE
7,192 bottles
DISTRIBUTION
Nationwide
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/.
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:
PRODUCT
Anastrozole tablets, 1 mg, 30 Tablets per HDPE Bottle, Rx only; NDC #63323-129-30; Product Code: 129030. Recall # D-906-2010
CODE
Lot numbers 870AF0010, Exp. date: 05/2012; Lot number: 870AF00201; Exp. date: 05/2012
RECALLING FIRM/MANUFACTURER
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.
REASON
Cross Contamination w/Other Products: A potential for some foreign tablets to be in bottles of anastrozole tablets 1 mg.
VOLUME OF PRODUCT IN COMMERCE
7,192 bottles
DISTRIBUTION
Nationwide
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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