American biopharmaceutical company Cubist Pharmaceuticals (Nasdaq: CBST) has issued a voluntary recall of certain lots of its infection-fighting drug Cubicin (daptomycin injection) to the user level due to the presence of glass particulate matter in vials produced by a contract manufacturer.
The presence of such matter when in an intravenous drug poses a potential safety risk such as thromboembolism, phlebitis or mechanical block of the capillaries or arterioles, with patients who have a pre-existing condition of trauma that affects the microvascular blood supply at increased risk. Glass particulates can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign matter.
No complaints of any glass particulate or adverse effects related to glass in vial have been reported for the recalled lots at present, but Cubist has still decided to recall them, and is notifying customers by letter and phone.
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