NEW DELHI: Drug companies Lupin and a subsidiary of Aurobindo Pharma have recalled products from the US market due to manufacturing issues, according to US health authorities.
Lupin's US unit has recalled medicines used to treat bacterial infections, according to the latest enforcement report issued by the United States Food and Drug Administration (USFDA).
Baltimore-based Lupin Pharmaceuticals is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) due to “failure to meet content uniformity specifications.”
The affected batches were produced at the company's manufacturing plant in Mandideep, Madhya Pradesh.
The company initiated a Class II nationwide recall on May 30th of this year.
U.S. health officials said Usea US LLC, a subsidiary of New Jersey-based Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate Injection USP.
The company is recalling the affected lots due to “failures in impurity/degradation specifications,” the USFDA said in a statement.
Eusea initiated a nationwide Class II recall on May 23rd of this year.
According to the USFDA, a Class II recall is initiated when use of or exposure to the violative product is likely to result in temporary or medically reversible adverse health effects, or is unlikely to result in serious adverse health effects.
U.S. health officials said Eusea is also recalling 15,500 single-dose vials of its injectable eptifibatide from the U.S. market.
This medicine helps prevent blood clots during chest pain or heart attack.
The USFDA said Usea was recalling the affected lots due to “failures in the impurity/degradation specifications.”
The company initiated a Class III recall on May 22nd of this year.
According to the USFDA, Class III recalls are initiated in “situations in which use of or exposure to the violative product is unlikely to cause adverse health effects.”
India is the largest supplier of generic medicines, producing 60,000 generic brands across 60 therapeutic areas, accounting for about 20 percent of the global supply.
Products manufactured domestically are shipped to over 200 countries around the world, with major destinations being Japan, Australia, Western Europe and the United States.
India has the largest number of USFDA compliant companies with factories outside the US.
Published on June 23, 2024 at 06:29 IST
