Dr Reddy's Laboratories has begun recalling five lots of its Ranitidine tablets, an anti-ulcer drug available over the counter, on account of microbial contamination.
The details pertaining to this were released by the US Food and Drug Administration (USFDA) in its August enforcement report.
Speaking to Business Today, the company spokesperson confirmed the recall. "We have done a voluntary recall of five lots of our Ranitidine because of microbial contamination. It is a class II recall."
The USFDA describes Class II recall 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."
The product, the spokesperson said, was manufactured at the company's Shreveport facility in the US. He added the financial impact would be negligible.
The reason for recall, the USFDA report says, was "microbial contamination of non-sterile products - a lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp".
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