Sun Pharma unit recalls Cephalexin capsules in US market
16 Aug 2014
Caraco Pharmaceutical Laboratories, the US arm of India's Sun Pharmaceutical Industries, has initiated a recall of multiple lots of Cephalexin capsules from the US market, according to a notification by the US Food and Drugs Administration.
Sun Pharma initiated the recall of 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles voluntarily through a letter to the USFDA in June, under 'Class-II' classification, the regulator said in a web site release.
Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, according to USFDA.
Cephalexin, an antibiotic that belongs to the family of medications known as cephalosporins, is used in the treatment of certain types of bacterial infections.
The drug, distributed by Caraco Phramaceutical in the US, was manufactured in India by Sun Pharma.
''These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices,'' USFDA added.
Caraco Pharmaceutical had earlier recalled some lots of Venlafaxine Hydrochloride extended-release tablets from the US market for not meeting the drug release dissolution specifications under 'Class-II' classification.
Another Indian pharma firm in the US, Wockhardt USA too has initiated a recall of 840 bottles of Bupropion hydrochloride extended-release tablets USP (SR), 100 mg (500-count bottle) from the US market citing m-chlorobenzoic acid impurity beyond the specified levels.
The recalled tablets were those used in the treatment of major depressive disorder.