Consumer Lawyers

Glaxo recalls some lots of Ca-channel blocker DynaCirc CR

In Uncategorized on February 28, 2012 at 2:45 am

GlaxoSmithKline has recalled >394 000 bottles of its calcium-channel blockerisradipine (DynaCirc CR) for hypertension, news outlets are reporting based on statements from the company.

The media reports follow a February 22 enforcement report from the FDA that stated that the company-initiated recall was based on irregularities with the product packing process at a Novartis factory in Lincoln, NE . Novartis manufactured the drug there for Glaxo.

The Wall Street Journal reported Friday that the Nebraska plant recently closed in order to respond to a problem identified by regulators. “Among the observations cited by FDA inspectors were reports of tablets of certain medicines being placed in bottles labeled for other products.”

Glaxo was informed by Novartis of the potential for DynaCirc CR “tablet mix-ups” at the plant but “has received no reports of adverse events or any complaints of foreign products or tablet mix-ups in any batches of DynaCirc,” according to a GlaxoSmithKline spokesperson quoted in the paper’s story.

The FDA enforcement report said the recalled lots include 30-count bottles of 5-mg and 10-mg controlled-release DynaCirc capsules with expiration dates primarily in 2013: lots 10084536, 10102915, 10102916, 10107157, 10108172, 10087732, 10091069, 10094639, 10102913, and 10109327.

 

http://www.theheart.org/article/1363045.do

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