Posted Jan. 18, 2011
American Regent Inc. has issued recalls of injectable sodium bicarbonate and injectable dexamethasone sodium phosphate because of particulate contamination.
In late December, the company recalled all unexpired lots of 7.5 percent and 8.4 percent injectable sodium bicarbonate in 50-mL single-dose vials. The national drug codes for the products are 0517-0639-25 and 0517-1550-25, respectively. Some vials of the products contain particulates.
Also in late December, American Regent recalled certain lots of 4 mg/mL injectable dexamethasone sodium phosphate in 30-mL multiple-dose vials, with the national drug code 0517-4930-25. Some vials contain particulates or have the potential to form particulates. The recall covers the following lots: 8811, expiration 12/2010; 9093, expiration 02/2011; 9195, expiration 03/2011; 9296, expiration 04/2011; 9419, expiration 06/2011; 9505, expiration 07/2011; and 9649, 09/2011.
Details about the recalls are at www.americanregent.com/newsevents.aspx.
Luitpold Pharmaceuticals Inc. manufactures injectable sodium bicarbonate and injectable dexamethasone sodium phosphate for American Regent.
Information about product recalls is available here.