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 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 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.
When contacted, a Sun Pharma spokesperson offered no comments.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories in the US while manufactured in India by Sun Pharmaceutical Industries.
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.
Recently Caraco Pharmaceutical had said that it initiated a recall of some lots of Venlafaxine Hydrochloride tablets from the US for not meeting the drug release dissolution specifications under 'Class-II' classification.