This site is intended for Healthcare professionals only.

Sun Pharma recalls over 2,500 bottles of diabetes drug from US


Sun Pharma recalls over 2,500 bottles of diabetes drug from US

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.



Source: PTI
1 comment(s) on Sun Pharma recalls over 2,500 bottles of diabetes drug from US

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted
  1. I sincerely hope that USFDA is monitoirng the metformin distributed in this country, whose source is not know to the consumers. Average consumer is not aware of the source of most generic drugs.