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GSK Recalling 400k Bottles of DynaCirc

Thu, 03/01/2012 - 12:12pm

 

LINCOLN, Neb. (AP) - A global pharmaceutical company is recalling nearly 400,000 bottles of a blood pressure drug that was packaged in Nebraska.

 

The Lincoln Journal Star reports that GlaxoSmithKline initiated a recall of the drug DynaCirc CR, which was made at the Novartis plant east of Lincoln.

 

Novartis manufactured the generic drug on a contract basis at the Lincoln site.

 

GlaxoSmithKline said in a statement it has received no complaints about contamination or tablet mix-ups. But the company cited a Food and Drug Administration report that found "compliance concerns" related to line clearance during the plant's packaging process.

 

The GlaxoSmithKline action is the second recall of drugs at the site this year. Novartis recalled several of its over-the-counter medicines in January, including Excedrin, Bufferin, GasX and NoDoz.

 

The following day, the FDA warned that pain medications Novartis manufactured in Lincoln for Endo Pharmaceuticals could have been contaminated with other products. But the FDA stopped short of ordering the drugs recalled.

 

Novartis shut down manufacturing at the Lincoln plant in mid-December after several scathing inspection reports from the FDA.

 

The FDA documented numerous repeat violations, including the failure to investigate consumer complaints and poor quality-control procedures that allowed some medicines produced there to become contaminated.

 

The shutdown already has cost Novartis more than $200 million, and the company has said it does not expect the plant to restart production until the summer.

 

Despite laying off more than 100 temporary workers, the company has kept all of the more than 600 permanent employees working during the shutdown.

 

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