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FDAnews Drug Daily Bulletin
Sept. 7, 2012 | Vol. 9 No. 176
Inspection of Pacira Plant Prompts EU Recall of Cancer Drug DepoCyte
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has urged Pacira Pharmaceuticals’ cancer drug DepoCyte be recalled in certain EU countries, citing “manufacturing deficiencies” found at the company’s San Diego, Calif., facility. The market correction follows a recent inspection of the plant by UK and French investigators that identified a lack of sterility assurance in the manufacturing process, the EMA said recently.
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