 "Lupin Pharma")
Lupin is recalling over 54,000 vials of anti-bacterial injection, Ceftriaxone, due to violation of current manufacturing norms.
The ongoing voluntary recall is a class-III recall for the US and Puerto Rico markets, according to the US Food and Drug Administration website.
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".
