Acetadote Recall Issued Due To Particulate Contamination

Six lots of Acetadote, an injection used to treat Tylenol overdoses, have been recalled due to particulate matter found in some of the vials. 

The FDA announced the Acetadote recall on January 1, indicating hat the contamination came from a former supplier. The distributer, Cumberland Pharmaceuticals, Inc. said it moved production away from that supplier in August 2009.

There have been no injuries or illnesses reported in connection with contaminated Acetadote and a Cumberland press release said that the risk of illness was remote.

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Acetadote (acetylcysteine) received FDA approval in 2004 for the treatment of the side effects of Tylenol or other acetaminophen-based drug overdose in order to prevent liver damage. It must be administered within eight to 10 hours after the potentially toxic dose of Tylenol.

The recall affects six lots of Acetadote injection, 20% solution in 30 mL single dose glass vials. The affected lots include lot numbers 090304 and 090331, with expiration dates of February 2011; 090401, with an expiration date of March 2011; 090511 with an expiration date of April 2011; and 090602 and 090616 with expiration dates of May 2011. The recalled vials were distributed worldwide.

Last week, the FDA told Cumberland that it had failed to provide enough evidence for the agency to approve Acetadote for the treatment of non-Tylenol related liver toxicity.

The recall also comes just two weeks after American Regent had to recall lots of dexamethasone and sodium bicarbonate due to particulate matter contamination.

The FDA recommends that any adverse reactions be reported to the FDA MedWatch Program online at www.fda.gov/medwatch.

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