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Hyderabad, 22 August: Dr Reddy's Laboratories Limited has initiated a voluntary recall of a few lots of Ranitidine Hydrochloride tablets of 150 mg strength in the US earlier this month, according to an enforcement report put out by the US Food and Drug Administration(US FDA),
The action comes in the wake of microbial contamination detected in the drug. "A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp," the report said.
"We have done a voluntary recall of five lots of our Ranitidine OTC because of microbial contamination. It is a class II recall. The product was manufactured at our facility in Shreveport, USA," the company spokesperson said when asked for a clarification on the development.
Ranitidine, an over the counter (OTC) drug, is indicated for short term treatment of active duodenal ulcer and also used to treat heart burn and acid indigestion. The company has initiated the recall of the drug on August 2 in Bridgewater city in New Jersey, according to the report. The tablets are distributed nationally, it said.
