Pharmaceutical drug makers, Sun Pharmaceutical Industries and Aurobindo Pharma are recalling some of their products in the US market due to standard manufacturing norms' deviations.
As per the latest administration report published by the USFDA (Food and Drug Administration), the US-based subdivision of Aurobindo Pharma is recalling around 1,15,776 bottles of Moxifloxacin Ophthalmic Solution, an antibiotic used for treating bacterial infections.
As per the agency, Aurobindo Pharma USA Inc. is reportedly recalling the affected product lot due to degradation specification/failed impurities. The Class II recall was initiated by the company on January 14 this year.
On a similar note, the FDA said that the US-based arm of Sun Pharma is recalling around 59,232 bottles of Chlorthalidone tablets, used for dropping the surplus fluid levels in the body.
According to the health regulator, Sun Pharma Inc. recalls the affected material owing to the external matter recognized as stainless steel microscopic wear particles assorted with punch lubricant oil and silicone particles from the dust cap.
The firm began the Class II voluntary recall in February this year.
The FDA states that a Class II recall is commenced in a situation where the use of or contact to an offensive product might cause momentary or medically reversible hostile health consequences or where the prospect of severe adverse health consequences is remote.
According to industry estimates, the US generic drug market was assessed to be around USD 115.2 billion in 2019. Recently, the shares of Aurobindo Pharma Ltd. traded 0.53 per cent down at Rs 621.8 ($8.25), as the BSE benchmark Sensex dropped 8.3 points to 55,850.22 ($741.47).
The scrip was settled at Rs 625.1 in the previous session. The stock recited a 52-week high value of Rs 1063.75 ($14.12) and a 52-week low of Rs 590.25 ($7.83).
Source Credit - https://www.business-standard.com/article/companies/aurobindo-sun-pharma-recall-products-in-us-market-for-defaulting-norms-122022700249_1.html