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Cadence Pharmaceuticals Announces Voluntary Recall of One Lot of OFIRMEV® (Acetaminophen) Injection
Date:2/6/2012

SAN DIEGO, Feb. 6, 2012 /PRNewswire/ -- 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."

Customer Recall ContactCustomers with questions regarding this recall should call 1-866-338-4070.About OFIRMEV® (Acetaminophen) InjectionOFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL; for intravenous use only), Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. The FDA approval of
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SOURCE Cadence Pharmaceuticals, Inc.
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