SUN PHARMA UNIT RECALLS MULTIPLE LOTS OF CAPSULES FROM U.S: Caraco Pharmaceutical Laboratories, a unit of Sun Pharma, has initiated a recall of multiple lots of Cephalexin capsules from the U.S. market. According to a notification by the USFDA, the recall of the 3.40 lakh units of 500 mg and 1.14 lakh units of 250 mg bottles is voluntarily initiated by the company through a letter to the regulator in June under ‘Class-II’ classification. Cephalexin is an antibiotic that belongs to the family of medications known as cephalosporins. It is used to treat certain types of bacterial infections. CGMP deviations These products were being recalled because they were not manufactured with good manufacturing practices, a USFDA’s website said citing the reason for recall. When contacted, a Sun Pharma spokesperson offered no comments. The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories in the U.S. while manufactured in India by Sun Pharmaceutical Industries. Recently, Caraco Pharmaceutical had said that it initiated a recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the U.S. market for not meeting the drug release dissolution specifications under ‘Class-II’ classification. Meanwhile, in another notification, USFDA said Wockhardt USA had initiated a recall of 840 bottles of Bupropion hydrochloride extended-release tablets USP (SR), 100 mg, (500-count bottle) from the U.S. market.
Posted on: Sun, 17 Aug 2014 03:28:54 +0000
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