 "Aurobindo Pharma recalls anti-epileptic drug in US")
Aurobindo Pharma’s US subsidiary has voluntarily recalled lot GESB14011-A of gabapentin capsules, USP 300 mg, 100-count bottles to the consumer level, as the product lot was found to contain some empty capsules.
“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,” stated Aurobindo Pharma USA in a filing to US FDA.
Aurobindo Pharma USA said that it has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules.
Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). Product was distributed through Northstar label to retail outlets nationwide.
“The company is notifying its distributors and customers by recall letters and is arranging for return of all recalled product. 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,” said Aurobindo Pharma USA in press release.
“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,” stated Aurobindo Pharma USA in a filing to US FDA.
Aurobindo Pharma USA said that it has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules.
Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). Product was distributed through Northstar label to retail outlets nationwide.
“The company is notifying its distributors and customers by recall letters and is arranging for return of all recalled product. 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,” said Aurobindo Pharma USA in press release.