BETHESDA, MD 10 August 2012—Forty-one lots of acetaminophen injection with expiration dates in July, August, or September are being recalled by Cadence Pharmaceuticals Inc. because of the presence of particulate matter, according to this week's FDA Enforcement Report.
The company, in reporting financial results on August 2, said it recalled the 41 lots of Ofirmev out of precaution. Those lots had been made by the original contract manufacturer, which had also made the single lot recalled in February.
Scott A. Byrd, Cadence's chief commercial officer, told financial analysts that the company did not expect any supply shortages of its product because the alternate contract manufacturer has been supplying new lots.
The original contract manufacturer, Baxter Healthcare Corporation, has not yet identified the root cause of the particulate matter in the vials, said Theodore R. Schroeder, Cadence's president.
Cadence estimated that fewer than 10,000 vials from the 41 lots remained on the market at the time the company started the recall.
According to FDA's Enforcement Report, the recall started July 24 and the 41 lots consisted of roughly one million vials.
The lots are V006015, V006023, V006031, V006056, V006064, V006080, V006106, V006114, V006130, V006148, V006155, V006171, V006189, V006197, V006205, V006213, V006221, V006254, V006262, V006270, V006296, V006304, V006312, V006320, V006338, V006346, V006353, V006361, V006379, V006387, V006395, V006403, V006429, V006437, V006445, V006460, V006494, V006510, V006528, V006536, and V006544.