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INDIA'S RANBAXY RECALLS DRUGS FOR SKIN DISEASE FROM US MARKET

Posted on: Mon, 23 Nov 2009 01:28:00 EST

Symbols: RBXLF

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NEW DELHI, Nov 23, 2009 (AsiaPulse via COMTEX) --
RBXLF | Quote | Chart | News | PowerRating -- Ranbaxy Laboratories
(BSE:500359) has recalled from the US market a batch of 4,348
cartons of Sotret Isotretinoin capsules used in treating skin
infections.

According to the information available on US health
regulator Food and Drug Administration's (FDA) website, Ranbaxy
through its US-based subsidiary Ranbaxy Laboratories Inc, has
issued a 'nation-wide class III recall' for a batch of Sotret
Isotretinoin capsules of 40 mg strength.

The company has issued the recall after ceratin reports
suggested that the product may "exceed impurity specifications"
during its shelf life period.

However, a class III recall signifies that the use of the
product is not likely to be harmful.

This is the second time in last four months that Ranbaxy has
initiated a recall. Earlier in July, it had called back a lot
of Sotret from the US market.

When contacted the spokesperson of Gurgaon-based firm said
this is a Class III recall and is being conducted with the full
knowledge of the USFDA.

"Ranbaxy Laboratories Inc, Princeton, New Jersy, is
conducting a voluntary recall of Sotret Isotretinoin Capsules,
USP 40mg, which is limited to a single batch, currently
available in the US market," the company said.

Asked about the impact of recall on company's revenues, the
company declined to comment over the issue.

(PTI) bl

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