Sun Pharma recalls 500,000 bottles of Cephalexin capsules from US

Caraco Pharmaceutical Laboratories, a unit of Sun Pharmaceuticals, initiated a recall of multiple lots of Cephalexin capsules from the US market. 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 was voluntarily initiated by the company in June under Class-II classification. Cephalexin is an antibiotic that belongs to the family of medications known as cephalosporins, used to treat certain types of bacterial infections.

These products were recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.

According to 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.