The company has made the decision to initiate a voluntary recall of Zinetac Tablets 150 mg and 300 mg products manufactured in India.
Shares of GlaxoSmithKline Pharmaceuticals declined 5 percent in early trade on September 26 after the company suspended the supply of India’s second-largest brand of acidity and heartburn medicine, Zinetac, following the ongoing probe by the USFDA into the reported cancer-causing impurity in Ranitidine-based drugs.
The company in its press release said that it has suspended the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations.
The company has been contacted by regulatory authorities regarding the detection of genotoxic nitrosamine NOMA in ranitidine products, it added.
Subsequently, Saraca Laboratories were notified by the European Directorate for V Quality of medicines that its certificate of suitability for ranitidine hydrochloride has been suspended.
The company manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg (Zinetac) using API from Saraca Laboratories and another supplier, SMS Lifesciences India Limited, for supply to Indian market.The company has made the decision to initiate a voluntary recall (pharmacy/retaillevel recall) of Zinetac Tablets 150 mg and 300 mg products manufactured in India using API sourced from Saraca
Laboratories Limited.At 0937 hrs, GlaxoSmithKline Pharmaceuticals was quoting at Rs 1,391.00, down Rs 44.45, or 3.10 percent on the BSE.