Business Daily from THE HINDU group of publications
Friday, Jul 10, 2009
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Business Daily from THE HINDU group of publications Friday, Jul 10, 2009 ePaper | Mobile/PDA Version | Audio | Blogs |
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Corporate
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Standards & Benchmarks
This is a Class-III recall which signifies that the use of the product is not likely to cause adverse health consequences. Our Bureau New Delhi, July 9 Ranbaxy Laboratories’ US subsidiary on Thursday said that it was recalling a single lot of a capsule used in the treatment of acne from the US market. Though the recall is voluntary, it has been done at the recommendation of the US Food and Drug Administration. “Ranbaxy Laboratories Inc, Princeton, NJ, is conducting a voluntary recall of Sotret Isotretinoin Capsules, USP 40mg, which is limited to Lot No.1876846 currently available in the US market. While Ranbaxy tested the lot in question and found it to be within specifications, based on USFDA’s testing and recommendation, and out of an abundance of caution given Ranbaxy’s commitment to the health and safety of patients, a recall has been initiated to the wholesaler/distributor level,” said a company statement. Class-III recallThe company added that this was a Class-III recall which signifies that the use of the product is not likely to cause adverse health consequences. “The recall is being conducted with the full knowledge of the USFDA,” it said. Ranbaxy’s share price was unaffected on the BSE. It increased by 2.14 per cent to close at Rs 253.5 on Thursday. Ranbaxy did not say what was wrong with the capsules being recalled. According to the FDA, Class-III recalls are for pharma and food products that violate manufacturing or labelling norms. No impact on revenuesThough a single lot would not have any significant impact on the company’s revenues the recall could have a negative impact on the brand. The USFDA has already banned 30 drugs being manufactured by Ranbaxy at its plant in Paonta Sahib. Indian drug makers have been put under the scanner by the US and European drug and health regulators. Lupin, Cipla, Jubilant and Sun Pharmaceuticals already face probes over issues related to manufacturing practice and drug quality. Medicis files suit against Ranbaxy Ranbaxy buys Ochoa Labs’ skin care range More Stories on : Standards & Benchmarks | Pharmaceuticals | Ranbaxy Laboratories Ltd
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