Treatment for Acetaminophen Overdose Recalled Because of Particulates

January 03, 2011

January 3, 2011 — Six lots of single-dose acetylcysteine injection (Acetadote), an antidote for acetaminophen overdose, have been recalled by its manufacturer, Cumberland Pharmaceuticals, because of the presence of particulate matter, the US Food and Drug Administration (FDA) announced on January 1.

The source of the particulates in the acetylcysteine injection under recall — 20% solution (200 mg/mL) in 30-mL single-dose glass vials — is from vials produced by a former supplier, according to Cumberland Pharmaceuticals. The company, which switched to a new vial supplier in August 2009, stated in a press release that the recall does not stem from any known adverse medical events.

The lot numbers being recalled are 090304 (expiration February 2011), 090331 (February 2011), 090401 (March 2011), 090511 (April 2011), 090602 (May 2011), and 090616 (May 2011).

Acetylcysteine prevents or lessens injury after ingestion of a possibly toxic amount of acetaminophen, a common ingredient in over-the-counter and prescription pain relievers. Acetaminophen overdose is a major cause of liver failure and liver transplantation in the United States.

More information about today’s announcement is available on the FDA Web site.

To report adverse events related to acetylcysteine injection, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.