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.”
The ongoing recall was initiated on March 30, 2016, the report said.
Ondansetron tablets are used for prevention of nausea and vomiting associated with cancer chemotherapy, radiation treatment or surgery.