Dr. Reddy’s Laboratories Ltd has voluntarily recalled three lots of its over-the-counter antacid drug Ranitidine Hydrochloride 150 mg in the US market.
An enforcement notification issued by US Food and Drug Administration (FDA) said the recall was initiated by the company because of “microbial contamination of non-sterile products”.
“A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp,” the FDA report said. Pseudomonas sp is a type of bacteria.
Dr. Reddy’s said the financial impact of the recall is “negligible”.
Ranitidine is manufactured at the Shreveport facility of Dr. Reddy’s in Louisiana. Ranitidine was the first generic product launched by Dr. Reddy’s in the US market.
Shares of Dr. Reddy’s rose by 3.66% to Rs.2,120 on BSE, while the exchange’s benchmark Sensex gained 2.27% to 18,312.94 points.