Lupin recalls over 54K vials from US

An enforcement report on US drug regulator’s website says that the ongoing voluntary recall of anti-bacterial injection, Ceftriaxone is a class III recall due to violation of current manufacturing norms


Mumbai: Lupin Pharmaceuticals Inc, a US subsidiary of Lupin, is recalling over 54,000 vials of anti-bacterial injection Ceftriaxone, which were manufactured at the company’s Mandideep facility in Madhya Pradesh.

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.

The company ended marginally low at Rs 1,427.95 on Bombay Stock Exchange (BSE) after it was reported that the company is recalling huge lots of anti-bacterial infection vials from US.

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”.

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.