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.

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E-mail ID will not be published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

  • Government must give up majority ownership in loss making PSU banks

    After four years of braving economic slowdown and provisioning for rising non performing assets (NPAs), public sector banks are in urgent of capital.

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

BK Chaturvedi

Cooperative federalism and governance

Improving relations between the states and the Centre to improve ...

Kuruvilla Pandikattu SJ

Reason drives religion, science

Both religion and science are driven by reason, claims Rama ...

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