New Delhi: The US arm of Sun Pharmaceutical Industries is recalling over 2,500 bottles of Metformin hydrochloride extended-release tablets from Arizona on account of the presence of a foreign substance in one lot.
United States Food and Drug Administration (USFDA) said the company is recalling 2,508 bottles of Metformin hydrochloride extended-release tablets 500 mg, packaged in a 500-count bottle.
The reason for the recall is the presence of foreign substance- one lot of these tablets contains foreign matter identified as a piece of rubber glove detected in one tablet, it added.
The tablets were manufactured at Sun Pharma’s Halol facility, USFDA said in its Enforcement report.
The ongoing, voluntary recall is a class II recall, it added.
As per USFDA, a class II recall is initiated in 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.”
Metformin hydrochloride extended-release tablets are used to improve glycemic control in adults with type 2 diabetes.