The ongoing voluntary nationwide recall has been classified as Class-I and Class-II recall.
New Delhi: 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 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 anti-bacterial 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 reconstituted 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. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life-saving drug, or a defective artificial heart valve.
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.
The USFDA has classified it as a Class-II recall, which 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”.
Similarly, Sun Pharmaceutical Industries is voluntarily recalling 13,918 cartons and 1,39,180 vials of Vecuronium Bromide for Injection, used as part of general anaesthesia, due to the presence of particulate matter.
Besides, Glenmark Pharmaceuticals is recalling 96,240 applicators of its product Estradiol Vaginal Inserts for a defective delivery system. The USFDA has termed it as a Class-II recall.