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Sun Pharma, Aurobindo recall products in US over defaulting norms

MD BureauWritten by MD Bureau Published On 2022-02-28T13:18:04+05:30  |  Updated On 28 Feb 2022 9:08 AM GMT
Sun Pharma, Aurobindo recall products in US over defaulting norms

New Delhi: 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...

New Delhi: 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 nationwide Class II recall on January 14 this year.

Read Also - Unichem, Aurobindo Pharma recall Topiramate, Carvedilol respectively in US

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''.

Read Also - Aurobindo Pharma launches COVID-19 drug Molnupiravir

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.

Read Also - Aurobindo Pharma in trouble for manufacturing lapses at API plant

Aurobindo Pharma Limited is a pharmaceutical company that manufactures generic pharmaceutical ingredients. The company works in six major therapeutic/product areas: antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics. Aurobindo Pharma's marketing partners include AstraZeneca and Pfizer. 

aurobindo pharma sun pharma usfda aurobindo pharma news sun pharma news moxifloxacin ophthalmic solution chlorthalidone tablets bacterial infections recall 
Source : with inputs
MD Bureau
MD Bureau

    Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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