Lupin recalling anti-bacterial drug Ceftriaxone from US

21 Jan 2019 Evaluate

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 company. The products have been manufactured at the company's facility in Mandideep in the state of Madhya Pradesh.

The company is recalling specific lots of drugs due to the presence of shredded rubber particulate matter from the stopper observed in reconstituted vials. 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. It is classified 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.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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