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Jubilant Cadista Pharmaceuticals Inc, is recalling over 1.58 lakh bottles of Pantoprazole Sodium delayed-release tablets manufactured by Jubilant Generics Ltd at its Roorkee plant, from the America and Puerto Rico market, the latest report of the US health regulator has said.
The tablets are used for the treatment of gastroesophageal reflux disease (GERD).
Jubilant Cadista Pharmaceuticals Inc is recalling 1,58,466 bottles of Pantoprazole Sodium delayed-release tablets USP in the strength of 40 mg, manufactured by Jubilant Generics Ltd, Roorkee, the Enforcement Report of the US FDA said.
The reason for recall is “Discoloration: presence of dark discoloration or brown spots on the edges of the tablets,” it added. The voluntary ongoing nationwide recall in the USA and Puerto Rico, is a class II recall, the report said.
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.”
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