New Delhi: Drug majors Dr Reddy’s Laboratories and Sun Pharma are recalling different products in the US market for manufacturing issues, according to the US Food and Drug Administration. As per the enforcement report by the US health regulator, the US-based arm of Dr Reddy’s Laboratories is recalling over 48,000 cartons of a drug used to treat sneezing, runny or stuffy nose. It is recalling 25,176 cartons of 30-count tablets and 22,968 cartons of 20-count tablets.
According to USFDA, Dr Reddy’s Laboratories is recalling the affected lot due to “failed stability specifications”.
New Jersey-based Dr Reddy’s Laboratories, Inc initiated the Class III recall on November 21 this year. As per USFDA, a Class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.
The health regulator further said the US-based arm of Sun Pharma is recalling 14,064 cartons of a medication to treat erosive esophagitis or heartburn caused by gastroesophageal reflux disease (GERD). The company is recalling the affected lot, produced at its Mohali plant, due to “discoloration”, it added.
Sun Pharmaceutical Industries Inc commenced the Class II voluntary recall in the US on July 25 this year. As per USFDA, a Class II recall is initiated in 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.
According to industry estimates, the US generic drug market was estimated at around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.