Dr Reddy's Recalls 50k Bottles of Ondansetron Tabs in US
New Delhi : Drug firm Dr Reddy's Laboratories is recalling over 50,000 bottles of Ondansetron tablets made at the company's Bachupally plant in India, on account of failed impurities/ degradation specifications.
Dr Reddy's Laboratories Inc is voluntarily recalling 50,280 bottles of Ondansetron tablets 4 mg in a nationwide ongoing recall due to "failed impurities/degradation specifications; 12 month stability time point," US Food and Drug Administration said in its latest Enforcement Report.
According to the report on the USFDA website, it is a class II recall.
As per the US health regulator, 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."