Six Lots of Acetadote Injection Voluntarily Recalled

Cumberland issues recall as a precautionary measure; is small potential for particulate matter

TUESDAY, Jan. 4 (HealthDay News) -- The U.S. Food and Drug Administration and Cumberland Pharmaceuticals Inc. have notified health care professionals of a recall of six lots of acetylcysteine (Acetadote) injection (20 percent solution [200 mg/mL] in 30 mL single dose glass vials) due to the potential presence of particulate matter.

Cumberland Pharmaceuticals recalled the six lots as a precautionary measure due to particulate matter found in a very small number of vials. The lots recalled are 090304 (expiration February 2011), 090331 (expiration February 2011), 090401 (expiration March 2011), 090511 (expiration April 2011), 090602 (expiration May 2011), and 090616 (expiration May 2011). The lots were distributed to U.S. wholesalers and distributors nationwide. The recall is not being issued based on any known adverse events.

Acetylcysteine is an agent administered intravenously in the emergency department within eight to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen in an effort to prevent or lessen hepatic injury. The company identified the source of the particulate matter as from the glass vial manufactured by a former supplier.

"We are recalling certain lots manufactured by a previous packaging supplier as a precautionary measure, and believe the risk of any serious adverse medical events to be remote," A.J. Kazimi, the chief executive officer of Cumberland Pharmaceuticals, said in a statement. "As part of ongoing quality assessment, we switched to a new vial packaging supplier in August of 2009."

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