<p> Caraco Pharmaceutical Laboratories , a unit of Sun Pharma, has initiated a recall of multiple lots of Cephalexin capsules from the US market.<br /><br /></p>.<p>According to a notification by the USFDA, the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is voluntarily initiatedby the company through a letter to the regulator in June under ‘Class-II’ classification.<br /><br />Cephalexin is an antibiotic that belongs to the family of medications known as cephalosporins. It is used to treat certain types of bacterial infections.<br /><br />“CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices,” USFDA’s website said citing the reason for recall.<br /><br />When contacted, a Sun Pharma spokesperson offered no comments.The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.<br /><br />Health consequences<br /><br />According to American health regulator USFDA, 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.<br /><br />Recently Caraco Pharmaceutical had said that it initiated a recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market for not meeting the drug release dissolution specifications under 'Class-II' classification.<br /><br />Meanwhile, in another notification FDA said Wockhardt USA has initiated a recall of 840 bottles of Bupropion hydrochloride extended-release tablets USP (SR), 100 mg, (500-count bottle) from USA market. <br /></p>
<p> Caraco Pharmaceutical Laboratories , a unit of Sun Pharma, has initiated a recall of multiple lots of Cephalexin capsules from the US market.<br /><br /></p>.<p>According to a notification by the USFDA, the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is voluntarily initiatedby the company through a letter to the regulator in June under ‘Class-II’ classification.<br /><br />Cephalexin is an antibiotic that belongs to the family of medications known as cephalosporins. It is used to treat certain types of bacterial infections.<br /><br />“CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices,” USFDA’s website said citing the reason for recall.<br /><br />When contacted, a Sun Pharma spokesperson offered no comments.The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.<br /><br />Health consequences<br /><br />According to American health regulator USFDA, 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.<br /><br />Recently Caraco Pharmaceutical had said that it initiated a recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market for not meeting the drug release dissolution specifications under 'Class-II' classification.<br /><br />Meanwhile, in another notification FDA said Wockhardt USA has initiated a recall of 840 bottles of Bupropion hydrochloride extended-release tablets USP (SR), 100 mg, (500-count bottle) from USA market. <br /></p>