Lupin recalls Quinapril tablets from US market

Pharma major Lupin has said its US subsidiary Lupin Pharmaceuticals Inc has initiated voluntary

RELATED ARTICLES

recall of multiple lots of Quinapril Tablets USP from the US market after failing impurity specification test.

According to information available with the US Food and Drug Administration (FDA), the recall was initiated by the company last September and as many as 53,160 bottles (30,264 bottles of 5 mg and 22,896 bottles of 10 mg) of both the drugs (90-count bottles) are being recalled under Class-II classification.

In 2006, Lupin received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Quinapril Tablets USP in 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is indicated to treat hypertension.

"During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval," FDA said citing the cause for the recall.

According to the US health regulator, Class II recall is 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.

Both the drugs were manufactured by Lupin at its Goa facility.

When contacted, Lupin in a statement said: "This is an old event and a voluntary recall for a small batch of Quinapril Tablets 5 mg and 10 mg strengths; a precaution on our part, and of no business consequence."

Lupin shares today settled lower by 1.14 per cent at Rs 865.90 apiece on the BSE.

Post new comment

E-mail ID will not be published
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.
Image CAPTCHA
Copy the characters (respecting upper/lower case) from the image.

EDITORIAL OF THE DAY

  • State-owned banks can ride technology surge to penetrate retail segment

    For the first time in recent history, two large private sectors banks, ICICI and Axis have reduced their headcounts.

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

Sarthak Raychaudhuri

vice-president, HR, Asia South Whirlpool of India

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

TODAY'S COLUMNS

Amita Sharma

The rabbit hole of outcome budgets

Would you tell me, please, which way I ought to ...

Zehra Naqvi

Dignity of labour is dignity of life

M Rafi Khan, a retired police IG, used to ...

Gautam Gupta

Retailers have it tough, thanks to e-commerce

For the past few months our focus has been on ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture