Leading homegrown drug makers Aurobindo Pharma and Sun Pharmaceutical Industries are recalling different products in the US market due to deviation from standard manufacturing norms.
According to the latest enforcement report issued by the US Food and Drug Administration (USFDA), the US-based arm of Aurobindo Pharma is recalling 1,15,776 bottles of Moxifloxacin Ophthalmic Solution, an antibiotic used in the treatment of bacterial infections.
According to the USFDA, the Princeton-based Aurobindo Pharma USA Inc is recalling the affected lot due to “failed impurities/degradation specifications”.
The company initiated the national Class II recall on January 14 this year.
The USFDA said the US-based arm of Sun Pharma is recalling 59,232 bottles of Chlorthalidone tablets, used for reducing excess fluid levels in the body.
As per the US health regulator, the New Jersey-based Sun Pharma Inc is recalling the affected lot 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.
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019.
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