Lupin recalls over 54K vials of anti-bacterial injection in US

NEW DELHI: Drug firm Lupin is recalling over 54,000 vials of anti-bacterial injection Ceftriaxone manufactured at its Mandideep facility in Madhya Pradesh due to violation of current good manufacturing norms.

The ongoing voluntary recall is a class III recall and is for the US and Puerto Rico, according to the latest enforcement report on USFDA site.

The recall is being initiated by the company's US arm Lupin Pharmaceuticals Inc covering 54,472 vials of Ceftriaxone for injection in various strengths, it added.

Citing reasons for the recall, the USFDA said "finished products manufactured (at Lupin Ltd's Mandideep plant were) using active pharmaceutical ingredients whose intermediates failed specifications".

The company is also recalling 741.171 kg of Ceftriaxone Sodium (Sterile) active pharmaceutical ingredient as it's API intermediates failed specifications, the report added.

Ceftriaxone for injection USP is used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

As per the USFDA a class III recall is initiated in "a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".