By John Gever, Senior Editor, MedPage Today
Published: December 30, 2010
Six lots of injectable acetylcysteine (Acetadote) manufactured by Cumberland Pharmaceuticals have been recalled because of particulate matter found in some vials, the company said.
The drug is used to prevent acute liver injury in patients taking potentially toxic amounts of acetaminophen.
Cumberland said it was not aware of any adverse events but was recalling the products as "a precautionary measure."
The company believes the particles originated in the product's glass containers, which were produced by a former supplier. Cumberland said it switched to a different source of vials in August 2009.
The exact product being recalled is Acetadote (acetylcysteine) Injection, 20% solution (200mg/mL) in 30 mL single dose glass vials, NDC 66220-107-30.
Affected lot numbers, with expiration dates, include 090304 and 090331 (February 2011), 090401 (March 2011), 090511 (April 2011), and 090602 and 090616 (May 2011).
The product was distributed to U.S. wholesalers and distributors nationwide.
Cumberland's announcement did not include specific instructions to hospitals or other providers who may have the product in stock. The company, based in Nashville, can be contacted at (877) 484-2700.
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