After finding out that one lot of Gabapentin Capsules 300 mg had empty capsules, Aurobindo Pharma, US, has recalled the lot.
"Empty capsules could result in missed dose(s) of Gabapentin resulting in adverse health consequences that could range from no effect, short-term reduction in efficacy, short-term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening,'' the US Food and Drug Administration (USFDA) said in a release on its Web site.
AdvertisementThe product was distributed under the Northstar label to retail outlets. Though no case of adverse event has been reported, four complaints of empty capsules have been received.
"Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase," the company advises.
Gabapentin is used for the treatment of epilepsy and manage postherpetic neuralgia.