Jubilant Cadista Pharmaceuticals Inc is recalling 63,216 bottles of pantoprazole sodium delayed-release tablets in the American market and Puerto Rico, as per the latest report of the US health regulator. The tablets are used for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD).
Jubilant Cadista Pharmaceuticals Inc is recalling 63,216 bottles of the tablets in the strength of 40 mg, manufactured by Jubilant Generics at its Roorkee plant, the Enforcement Report of the US Food and Drug Adminstration (USFDA) said.
The reason for the recall is “CGMP Deviation: Presence of dark brown discolouration on edges of tablets,” it added.
The ongoing voluntary recall is a class II recall, the report said.
“The product was distributed to Mississippi (MS), Ohio (OH), Rhode Island (RI), Tennessee (TN) and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level,” it 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.”