Drugmaker Recalls Six Lots of Acetadote

Cumberland Pharmaceuticals Inc. is recalling six lots of Acetadote (acetylcysteine) injection. The 20 percent solution (200 mg/mL), 30 mL single dose glass vials are being recalled because of particulate matter observed in a “very small” number of vials, the drugmaker says in a press release.

Used in the emergency department (ED), Acetadote (HCPCS Level II code J0132 Injection, acetylcysteine, 100 mg) is administered intravenously within eight to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen to prevent or lessen hepatic injury. Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers.

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

In other news: Cumberland Pharmaceuticals announced Jan. 13 that it has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Acetadote injection.

The new formulation does not contain ethylenediaminetetracetic acid (EDTA) or any other stabilization and chelating agents and is preservative-free.


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