25 November 2014 | Regulatory | By BioSpectrum Bureau
Aurobindo recalls epilepsy drug lot in US
Aurobindo Pharma in the US is recalling Gabapentin drug lot for containing empty capsules
Singapore: India-based Aurobindo Pharma in the US is recalling Gabapentin capsules, USP 300 mg 100-count bottles, at consumer level due to possible stashs of some empty capsules.
USFDA has advised that 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.
Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles).