Sun Pharma recalls antidepressant drug from US market

Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma, has initiated recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market.

According to a notification by the FDA, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily initiated by the company through a letter to the regulator last month under 'Class-II' classification.

Venlafaxine Hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder.

"Stability results found the product did not meet the drug release dissolution specifications," the regulator's website said.

Tablet dissolution is a standardised method for measuring the rate of drug release from a dosage form.

The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd in USA, while manufactured at Halol plant in Gujarat by Sun Pharmaceutical Industries Ltd.

According to the US health regulator, Class II recall is a situation in which the 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.

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E-mail ID will not be published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.

EDITORIAL OF THE DAY

  • Time for banks to pass on RBI rate cuts to stakeholders of the economy

    Reserve Bank of India’s decision to cut the repo rate by 25 basis points, from 7.75 to 7.50, is a move in the right direction.

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

Chander Mohan Sethi

CMD, Reckitt Benckiser India

COLUMNIST

Amita Sharma

IITs: Growing needs with growing numbers

In continuance of the government’s commitment to spread the reach ...

Zehra Naqvi

For the love of language

A video doing the rounds in social media these days ...

Dharmendra Khandal

‘Poop’ coffee anyone? If civets suffer, so be it

That a drink which proudly associates itself with animal poop ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture