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Ranbaxy Recalls Acne Medication From US Market

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-IndianExpress

11/23/2009 - Ranbaxy Laboratories has recalled from the US market a batch of 4,348 cartons of Sotret Isotretinoin capsules used in treating nodule acne and other various forms of skin infections. Sotret and Isotretinoin are generic forms of the popular Acne medication Accutane. Other generic forms of Accutane are Amnesteem and Roaccutane.

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 'nationwide class III Sotret Recall' for a batch of Sotret Isotretinoin capsules of 40 mg strength.

The company has issued the recall after certain 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 Sotret or Isotretinoin 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 Jersey, 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 Sotret recall on company's revenues, the company declined to comment over the issue.

Sotret Side Effects

Sotret and Isotretinoin as well as the other generic versions of Accutane, Roaccutane and Amnesteem have been known to cause serious side effects such as Inflammatory Bowel Disease also known as IBD, Ulcerative Colitis and Crohn's Disease. Why these drugs cause the above side effects is not fully known but if you have experienced stomach issues or rectal bleeding you should consult with your physician.

If you have taken Accutane, Isotretinoin or Sotret and experienced serious side effects call our Isotretinoin lawyer today to find out if you are entitled to compensation. With offices in Washington D.C. and throughout Florida we are ready to help Isotretinoin side effects victims nationwide. Let our Accutane Attorneys evaluate your case for free today. Fill out our online case evaluation form on this page or call us toll free at: 1-800-856-6405 for your free, confidential case evaluation.

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