Aurobindo Pharma’s US subsidiary has said it has voluntarily recalled 300-mg, 100-count bottles of Gabapentin capsules. The lot has been found to contain some empty capsules.
Aurobindo Pharma USA said in a release that empty capsules could result in missed doses 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.
Aurobindo Pharma USA noted 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 in treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, having an expiry date of December 2015 and packaged in 100-count bottles, NDC 16714-662-01.
The company stated that the product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. The product was distributed through Northstar label to retail outlets nationwide.
The company advised that consumers, distributors and retailers having the said product should stop using, distributing and dispensing the affected lot, and return it to the place of purchase.