Sun Pharma Recalls Medicines Due to Manufacturing Defects In US - medtigo



Sun Pharma Recalls Medicines Due to Manufacturing Defects In US

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According to the US Food and Drug Administration, Dr. Reddy’s Laboratories and Sun Pharma are recalling separate goods from the United States market due to production concerns.  

The US division of Dr. Reddy’s Laboratories is recalling over 48,000 cartons of a medicine used to treat sneezing, a runny or stuffy nose, according to a notification by the US health authorities. PTI reports that the company is recalling 25,176 cartons of 30-count tablets and 22,968 cartons of 20-count tablets.  

According to the U.S. Food and Drug Administration, Dr. Reddy’s Laboratories is recalling the concerned batch because it “failed stability specifications.”  

Dr. Reddy’s Laboratories, Inc. began the Class III recall on November 21 this year, according to reports. According to the USFDA, a Class III recall is started when “use or exposure to a violative product is unlikely to result in significant health consequences.”  

As per Financial Express, the health regulator added that Sun Pharma’s subsidiary in the United States recalled 14,064 cartons of a drug used to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease (GERD). The contaminated lot, manufactured at the company’s Mohali factory, is being recalled owing to “discoloration,” the company noted.  

On July 25 of this year, Sun Pharmaceutical Industries Inc. initiated the Class II voluntary recall in the United States. In accordance with the USFDA, a Class II recall is undertaken when use or exposure to a violative product may result in transitory or medically reversible adverse health effects or when the likelihood of major adverse health effects is remote.  

According to industry estimates, the US market for generic drugs was valued at approximately 115.2 billion USD in 2019. It is the largest pharmaceutical product market. 

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