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Jubilant Life Sciences arm recalls 12960 bottles of Pantoprazole Sodium delayed release tablets


Jubilant Life Sciences arm recalls 12960 bottles of Pantoprazole Sodium delayed release tablets

The reason for the recall of 2,960 bottles of Pantoprazole Sodium delayed-release tablets by Jubilant Life Sciences’ arm, Jubilant Cadista is “Discoloration: expansion of an earlier recall due to the presence of dark brown discolouration on the edges of the tablets”.

New Delhi: 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.

Read Also: Jubilant Life Sciences settles IFC loan with over Rs 937 crore payout

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 Administration (USFDA) said.

The reason for the recall is “Discoloration: expansion of an earlier recall due to the presence of dark brown discolouration 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.

Read Also: USFDA recommends regulatory action after Jubilant Life Roorkee plant inspection

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.”

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MD Team

MD Team

At Medical Dialogues, we are a team of young professionals strongly advocating of the transparency in the medical sector through the free flow of medical information, health and medical news. MD Team covers a variety of news related to the healthcare, pharma and medical device industry in India. Our team can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751


Source: PTI
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