Sun Pharma’s anti-bacterial drug being recalled in US market
Thursday, June 23, 2016
As many as 2,839 bottles of anti-bacterial medicine Nitrofurantoin Oral Suspension manufactured by Sun Pharmaceutical Industries are being recalled in the US market on account of failed dissolution specifications.
The ongoing nationwide voluntary recall by Nostrum Laboratories Inc. for Nitrofurantoin Oral Suspension, USP, 25 mg/5 ml is a class II recall, according to the latest enforcement report on the United States Food and Drug Administration (USFDA) website.
The 2,839 bottles were manufactured and distributed by Sun Pharmaceutical Industries, it added. Citing reasons for the recall, the USFDA said it was due to “failed dissolution specifications”.
Nitrofurantoin oral suspension, USP is specifically indicated for the treatment of urinary tract infections. As per the 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”.
Source : livemint.com
