Ranbaxy recalls over 4000 cartons of acne drug in US Economic Times
NEW DELHI: Ranbaxy Laboratories has
initiated a voluntary recall of 4,348 cartons of its best-selling drug Sotret
(isotretinoin, 40 mg) used to treat acne in the US, as they are a part of one
batch of tablets which were found to be ‘out of specification’.
The revenue impact due to the recall is insignificant to the
company, a person familiar with the matter said.
Sotret is made at
the company’s Paonta Sahib plant in India and figures among the list of 30
drugs banned by the US Foods and Drugs Administration (FDA) after the American
regulator found manufacturing deficiencies at Ranbaxy’s two plants in the
country. But the FDA had allowed the company to sell it products that were
already supplied in the US market.
The product recall, categorised
as a ‘Class III recall’, which means the use of the drug is unlikely
to cause adverse health effects to patients, is from the remaining inventory in
the US market.
In July, Ranbaxy, now owned by Japan’s Daiichi
Sankyo, had also recalled another batch of the same medicine after it failed a
dissolution test to assess the uniformity and stability of the drug.
Source:
News
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