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HindustanTimes Tue,21 Oct 2014

Sun Pharma unit recalls mutiple lots of capsules from US

PTI  Hyderabad, August 15, 2014
First Published: 11:11 IST(15/8/2014) | Last Updated: 11:13 IST(15/8/2014)

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, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.

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.


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