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.

EDITORIAL OF THE DAY

  • Mob rage against the Tanzanian woman betrays racial and gender prejudices

    The mob rage in Bangalore against the Tanzanian woman is a national disgrace from which we can never recover even if we punish the wrong doers.

FC NEWSLETTER

Stay informed on our latest news!

TODAY'S COLUMNS

Sachin Shridhar

VIPism is casteism by another name

Much has been written and lamented about the all-pervasive VIP ...

Zehra Naqvi

‘What if the British never came to India?’

Legendary Canadian writer Margaret Atwood proves as elusive to the ...

Bubbles Sabharwal

It's the life in your years that counts

We are all in a sense pilgrim souls enjoying the ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture