Sun Pharma unit recalls mutiple lots of capsules from US

Caraco Pharmaceutical Laboratories, a unit of Sun Pharma, has initiated a recall of multiple lots of Cephalexin capsules from the US market.

According to a notification by the USFDA, the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is voluntarily initiated by the company through a letter to the regulator in June under 'Class-II' classification.

Cephalexin is an antibiotic that belongs to the family of medications known as cephalosporins. It is used to treat certain types of bacterial infections.

"CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices," USFDA's website said citing the reason for recall.

When contacted, a Sun Pharma spokesperson offered no comments.

The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories in the US while manufactured in India by Sun Pharmaceutical Industries.

According to American health regulator USFDA, 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.

Recently Caraco Pharmaceutical had said that it initiated a recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market for not meeting the drug release dissolution specifications under 'Class-II' classification.

Meanwhile, in another notification FDA said Wockhardt USA has initiated a recall of 840 bottles of Bupropion hydrochloride extended-release tablets USP (SR), 100 mg, (500-count bottle) from USA market. The reason for recall: "Out of specification levels of the impurity m-chlorobenzoic acid were observed". Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder.

EDITORIAL OF THE DAY

  • Allow 100 per cent FDI in asset reconstruction companies

    The asset reconstruction business is 13 years old and still struggling like a toddler.

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

Arun Nigavekar

Moocs will not replace traditional education

I am revisiting the topic of massive open online course ...

Rajgopal Nidamboor

From complexity to prudent adaptability

It is a travesty that a host of new, strikingly ...

Dharmendra Khandal

Creepy, you say? That’s merely ophidiphobia

Snakes are the earliest predators in the life of the ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture