Three multinational companies, including Actavis recently, have recalled medicines made in their Indian units in last six months; many local companies have recalled drugs in recent times.
The spate of drug recalls from India seems unending with multinational pharma companies too recalling medicines made in their facilities here.
Recently, a subsidiary of Actavis Plc initiated a voluntary recall of certain batches of its epilepsy drugs manufactured in India from Puerto Rico, according to the US Food and Drug Administration (FDA).
According to information available on the US FDA website, Actavis Elizabeth LLC, a subsidiary of the Dublin-based Actavis is recalling a total of 64,719 bottles of gebapentin capsules, USP, of strengths 100 mg, 300 mg and 400 mg due to "clumping and breaking of capsules". The capsules were manufactured at the drugmaker's Tamil Nadu facility.
The drug is used in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles).
There was a recall of around 29,622 bottles of 100 mg gebapentin capsules in 100 capsules per bottle with an expiry of October 2015, and in 500 capsules per bottle with an expiry of March 2016.
For the 300 mg, a recall of 24,240 bottles in 100 capsules per bottle was initiated with an expiry of one lot in September 2015 and the other in October 2015.
Similarly, 10,857 bottles of 400 mg gebapentin capsules in 100 capsules per bottle with an expiry of June 2015 and in 500 capsules per bottles with an expiry of August 2015 have also been initiated.
In one of the notifications by FDA on its website, it said that the capsules were manufactured by Actavis Pharma Manufacturing Pvt Ltd in Kanchipuram Dist in Tamil Nadu, and distributed by Actavis Elizabeth LLC.
In all three cases the reasons for recalls were given as, "Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center."
All three recalls, classified Class II, were initiated on December 15, 2014. According to FDA, a 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.
In the past six months, two other foreign pharma companies such as Canada-based Apotex and US-based Aidarex Pharmaceuticals LLC have also recalled drugs manufactured in India. Aidarex recalled a batch of antibiotic ciprofloxacin 500 mg manufactured by Unique Pharmaceutical Laboratories, Mumbai, while for Apotex there have been multiple recalls of hypertension drug candesartan cilexetil tablets in various dosages from its Bangalore facility.
The Canadian company's two other facilities in Bangalore also received an import ban from the US FDA, following which the Canadian health regulator Health Canada also imposed an import ban on the products manufactured by Apotex Pharmachem India Pvt Ltd and Apotex Research Pvt Ltd. Apotex Pharmachem's Bangalore unit received an import alert from FDA in April 2014, while Apotex Research's Bangalore plant was issued an import alert in September 2014.
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