2,839 bottles of Sun Pharma Inc being recalled in US
New Delhi : 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 USFDA site.
The 2,839 bottles were manufactured and distributed by Sun Pharmaceutical Industries Inc, it added.
Citing reasons for the recall, the United States Food and Drug Administration (USFDA) said 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".