American Regent Drug Recall Expanded to Include Sodium Bicarbonate

American Regent Inc. has recalled more drugs due to particulate matter found floating in vials of sodium bicarbonate. The recall comes just days after the company recalled injections of dexamethasone for the same problem. 

The sodium bicarbonate injection recall was announced on December 23 by American Regent, three days after the company had to recall dexamethasone sodium phosphate injections, according to a December 28 FDA press release.

American Regent is warning that the particles could cause damage to blood vessels in the lung, swelling and granuloma formation. The company did not report whether there were any injuries or deaths related to the contaminated drugs.

Sodium bicarbonate injections are used to treat metabolic acidosis, which can be caused by severe kidney disease, circulatory problems, diabetes, heart attach or lactic acidosis. It is also used to treat some drug addictions and severe diarrhea.

The recall affects all unexpired lots of sodium bicarbonate injection, USP, 7.5% and 8.4% in 50 mL single dose vials. The doses were manufactured by Luitpold Pharmaceuticals and distributed by American Regent. The recalled lots have expiration dates ranging from December 2010 through November 2012.

On December 20, American Regent also recalled dexamethasone sodium phosphate injections, which have also been found to contain particles that formed before the expiration date. There have been no reported injuries or deaths with that recall either.

The company has not detailed the nature of the contaminating particles, nor has it released information on how the contamination occurred.

The company has said it will credit the accounts of its customers for all returned affected products. Anyone with questions can call the company’s customer service department at 1-800-645-1706.