NEW DELHI, Apr 14: Jubilant Cadista Pharmaceuticals Inc is recalling 12,960 bottles of Pantoprazole Sodium delayed-release tablets from the American market, as per a report of the US health regulator.
The tablets are used for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD).
Salisbury-based Jubilant Cadista Pharmaceuticals Inc is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of Noida-based Jubilant Life Sciences.
Jubilant Cadista Pharmaceuticals Inc is recalling 12,960 bottles of the tablets in the strength of 40 mg, manufactured by Jubilant Generics Ltd at its Roorkee plant, the Enforcement Report of the US Food and Drug Adminstration (USFDA) said.
The reason for recall is “Discoloration: expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets”.
In October 2018, Jubilant Cadista Pharmaceuticals had said it was recalling over 1.58 lakh bottles of Pantoprazole Sodium delayed-release tablets, manufactured by Jubilant Generics Ltd at its Roorkee plant, from the US and Puerto Rico.
The ongoing voluntary nationwide recall in the US is a class II recall, the report added.
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.” (PTI)