Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, 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.
"We regret that some of our customers experienced short-term supply
delays due to our temporary suspension of shipments from the supplier of
lot V005710," said Scott Byrd,
Chief Commercial Officer of Cadence. "Fortunately, we were successful
in our efforts to accelerate shipments of OFIRMEV from another supplier,
which allowed us to quickly resume normal shipments of the product. We
do not anticipate any further supply delays."