Glenmark Pharmaceuticals recalls 2,904 bottles of Rantidine tablets in US mkt

Written by PTI | New Delhi | Updated: Apr 18 2014, 00:28am hrs
GlenGlenmark Pharmaceuticals shares closed at Rs 582.45 apiece on the BSE, down 0.11 pct from its previous close. Thinkstock
Glenmark Pharmaceuticals Ltd is voluntarily recalling 2,904 bottles of Rantidine Tablets, used to treat ulcers of the stomach and intestines, in the US market, according to the US Food and Drug Administration.

According to information available on the USFDA website, Glenmark Generics Inc, the US-based unit of the company, is recalling 2,904 bottles due to the presence of a foreign material in one of the bottles.

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"Recall is due to a pharmacist complaint of a foreign material, identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg," USFDA said.

The 150-mg tablets in 500-count bottles, were manufactured by Shasun Pharmaceuticals for Glenmark Generics Inc, it added.

The nationwide recall was initiated on March 18 this year.

It has been classified as a 'Class-II recall' which FDA defined as "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".

When contacted, a Glenmark spokesperson said: "We have voluntarily recalled 2,904 bottles of Ranitidine Tablets, 150 mg from one lot of material. The product was manufactured at our partner's manufacturing site. Corrective actions have been implemented and the recall is limited to only one lot of material."

Glenmark shares today closed at Rs 582.45 apiece on the BSE Sensex, down 0.11 per cent from its previous close.