Sun Pharma Recalls Their Products In US For Manufacturing Issues
December 6, 2022: The US Foods and Drug Administration said Sun Pharma’s US-based unit is recalling 14,064 cartons of the drug to treat erosive esophagus or heartburn due to gastroesophageal reflux disease (GERD).
The company is recalling the affected flour produced at its Mohali plant due to “discoloration”. The US According to the Food and Drug Administration, major drug companies Dr. Reddy’s Laboratories and Sun Pharma US are recalling various products from the market for manufacturing issues.
According to a US health regulator’s enforcement report, Dr. The US-based arm of Reddy’s Laboratories is recalling more than 48,000 cartons of the 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 lots due to “failed stability specifications”.
New Jersey-based Dr. Reddy’s Laboratories initiated the Class III recall on November 21 this year. According to the USFDA, a Class III recall is “initiated in situations where the use of, or exposure to, the offending product is unlikely to result in adverse health consequences”.
The health regulator further said Sun Pharma’s US-based arm is recalling 14,064 cartons of the drug to treat erosive esophagitis or heartburn due to gastroesophageal reflux disease (GERD).
The company is recalling the affected flour produced at its Mohali plant due to “discoloration”. Sun Pharmaceutical Industries Inc initiated a Class II voluntary recall in the US on July 25 this year.
According to the USFDA, Class II recalls are initiated in situations where use or exposure to the offending product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote.
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.
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