MUMBAI, India Ranbaxy Laboratories has initiated a voluntary recall of 73 million gabapentin tablets because the allowed level of impurities in the tablets exceeded their specific limitations, according to the Food and Drug Administration.
The drug which is used to help control certain types of seizures in patients who epilepsy, is available in 100, 300, 400, 600 and 800 mgs. The affected dosages are the 600 and 800 mg tablets.
“Ranbaxy is carrying out a voluntary recall of all lots of its 600mg and 800mg gabapentin tablets at the retail level as it found the presence of related substances permitted in the products to be outside the approved limit,” the spokesman said.
The company could not comment on whether the recall will create a shortage of its tablets, which contain the active ingredient in Pfizer’s off-patent drug Neurontin..