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Cadence Pharmaceuticals, Inc.
CADX announced today the voluntary recall of a single lot of OFIRMEV® (acetaminophen) injection. Cadence has notified the U.S. Food and Drug Administration of the recall.
The recall of OFIRMEV lot number V005710 was initiated due to the presence of an unidentified, visible particle in one vial of this lot during routine stability testing. Lot V005710 was distributed by Cadence to hospitals, wholesalers and distributors beginning in January 2011, and Cadence believes that fewer than 1,000 vials currently remain in the marketplace. Cadence has not received any reports of adverse patient events associated with particulate matter in the product, and has undertaken the recall as a precautionary measure.
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