Indian firms recall drugs in US market
INDIAN DRUG majors Lupin, Sun Pharma and Glenmark Pharmaceuticals are recalling various drugs from the US market for a variety of reasons.
As per the at latest Enforcement Report published by the US Food and Drug < Administration (USFDA), Lupin is voluntarily recalling 55,000 vials and 1,60,241 boxes of antibacterial drug Ceftriaxone for injection in various strengths.
The recall has been initiated by Lupin Pharmaceuticals, Inc, a subsidiary of the Mumbai-based firm. The products have been manufactured at the company's facility in Mandideep, Madhya Pradesh.
The company is recalling specific lots of drugs due to the presence of particulate matter. Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstl- J tuted vials, USFDA said.
' The ongoing voluntary nationwide recall has been classified as Class-I. Such recalls are for dangerous or defective products that predictably could cause serious health problems.
Lupin Pharmaceuticals is also recalling 2,87,784 bottles of Cefdinir for Oral Suspension, used to treat bacterial infections, for CGMP (Current Good Manufacturing Practice) deviations.