Recall of anti-seizure drug, Divalproex, involved four lots of bottles containing different counts and strength of tablets

Hyderabad, July 01, 2015 – A year after the last recall of its generic hypertension drug Metroprolol, Hyderabad-based Dr Reddy’s Laboratories Limited has initiated a nationwide voluntary recall of two more drugs earlier this month -Divalproex Sodium extended release tablets and Amlodipine Besylate and Atorvastatin Calcium tablets- from the US.

According to the the US Food and Drug Administration (US FDA), the recall of anti-seizure drug, Divalproex, involved four lots of bottles containing different counts and strength of the tablets.

Also four lots of the anti-hypertension drug Amlodipine Besylate and Atorvastatin Calcium tablets in different counts and strength were being taken out from the US market by Dr Reddy’s.

Both the drugs are manufactured at the company’s Bachupally facility in Hyderabad.

Divalproex recall comes under class 2 classification, which means use of the product may cause temporary or reversible adverse consequences, for failed dissolution as it exceeded specification at 9 hour point.

The second drug’s recall was classified as class 3, means there was no immediate or perceived danger of any health issues though it amounts to violation of US FDA regulations. The specific lots of Amlodipine combination drug was recalled for being subpotent.

The company had launched Divalproex in US in August, 2013 and Amlodipine Besylate and Atorvastatin Calcium tablets were launched in June last year.

The company has not responded to queries about the impact of these recalls. However, Sarabjit Kour Nangra of Angel Broking said there would be not much impact from voluntary recall of these specific lots of drugs from the US.

Last year, the company initiated voluntary recalls twice, including that of heartburn drug Lansoprazole for microbial PTI

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