Press Release: European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories

The European Medicines Agency, on 22 November 2011, issued a press release relating to shortcomings in quality assurance identified during a good-manufacturing-practice (GMP) inspection at the Ben Venue Laboratories manufacturing site in Ohio, United States of America, and their impact on centrally authorised medicines manufactured at this site.

The Agency issued a precautionary recall for remaining batches of Busilvex, Velcade and Vidaza manufactured at Ben Venue and advised that no new patients should be treated with Caelyx.

• Primary Source

EMA: Press Release: EMA/CHMP/954737/2011 (9.12.11): European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/12/news_detail_001402.jsp&mid=WC0b01ac058004d5c1

EMA: Press Release: EMA/CHMP/964006/2011 (13.12.11): European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/12/news_detail_001405.jsp&mid=WC0b01ac058004d5c1

EMA: Press Release: EMA/905564/2011 (22.11.11) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/11/WC500117924.pdf

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