New Delhi, drugmaker Lupine and a unit of Aurobindo Pharma are recalling products from the US market due to manufacturing issues, according to the US health regulator.
According to the latest Compliance Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupine is recalling a drug used to treat bacterial infections.
Baltimore-based Lupine Pharmaceuticals Inc is recalling 3,552 vials of cefixime for oral suspension (USP 200 mg/5 mL) due to "failed content uniformity specifications."
The affected batch was produced at the company's manufacturing plant in Mandideep in Madhya Pradesh.
The company initiated the nationwide (US) Class II recall on May 30 of this year.
The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of dexamethasone sodium phosphate injection USP.
The company is recalling the affected lot due to "failed impurity/degradation specifications," the USFDA said.
Eugia initiated the nationwide Class II recall on May 23 of this year.
According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an infringing product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote. .
Eugia is also recalling 15,500 single-dose vials of injectable eptifibatide from the US market, the US health regulator said.
The medication prevents blood from clotting during episodes of chest pain or a heart attack.
Eugia is recalling the affected lot due to "failed impurity/degradation specifications," the USFDA said.
The company began the Class III recall on May 22 of this year.
According to the USFDA, a Class III recall is initiated in a “situation in which use of or exposure to an infringing product is not likely to cause adverse health consequences.”
India is the largest supplier of generic medicines, with around 20 per cent of the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
Products manufactured in the country are sent to more than 200 countries around the world, with Japan, Australia, Western Europe and the United States being the main destinations.
India has the largest number of FDA-compliant companies with plants outside the United States.
According to the latest Compliance Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupine is recalling a drug used to treat bacterial infections.
Baltimore-based Lupine Pharmaceuticals Inc is recalling 3,552 vials of cefixime for oral suspension (USP 200 mg/5 mL) due to "failed content uniformity specifications."
The affected batch was produced at the company's manufacturing plant in Mandideep in Madhya Pradesh.
The company initiated the nationwide (US) Class II recall on May 30 of this year.
The US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of dexamethasone sodium phosphate injection USP.
The company is recalling the affected lot due to "failed impurity/degradation specifications," the USFDA said.
Eugia initiated the nationwide Class II recall on May 23 of this year.
According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an infringing product may cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote. .
Eugia is also recalling 15,500 single-dose vials of injectable eptifibatide from the US market, the US health regulator said.
The medication prevents blood from clotting during episodes of chest pain or a heart attack.
Eugia is recalling the affected lot due to "failed impurity/degradation specifications," the USFDA said.
The company began the Class III recall on May 22 of this year.
According to the USFDA, a Class III recall is initiated in a “situation in which use of or exposure to an infringing product is not likely to cause adverse health consequences.”
India is the largest supplier of generic medicines, with around 20 per cent of the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.
Products manufactured in the country are sent to more than 200 countries around the world, with Japan, Australia, Western Europe and the United States being the main destinations.
India has the largest number of FDA-compliant companies with plants outside the United States.
