Sun Pharmaceutical Industries’ US based arm -- Sun Pharma Inc is recalling 59,232 bottles of Chlorthalidone tablets, used for reducing excess fluid levels in the body. As per the US health regulator, Sun Pharma Inc is recalling the affected lot in US market due to ‘foreign matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup’. The company initiated the Class II voluntary recall on February 7, 2022.
As per the 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.
Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
