The U.S. arm of Sun Pharmaceutical Industries is recalling over 2,500 bottles of metformin hydrochloride extended release tablets from Arizona on account of presence of foreign substance in one lot.
The United States Food and Drug Administration (U.S. FDA) 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 recall is presence of foreign substance - one lot of these tablets contains foreign matter identified as a piece of rubber glove detected in one tablet. The tablets were manufactured at Sun Pharma's Halol facility. The ongoing, voluntary recall is a class II recall.U.S. FDA in its Enforcement Report
As per U.S. FDA, 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.
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