FYI....Contamination Prompts Recall of Liver Protectant

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Contamination Prompts Recall of Liver Protectant

By 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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Contamination Prompts Recall of Liver Protectant

By 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.