Aurobindo Pharma USA has issued a voluntary recall of its 300mg, 100-count bottles of Gabapentin capsules after the lot was found to contain several empty capsules.
Gabapentin is used in the treatment of epilepsy and postherpetic neuralgia. To date, four complaints of empty capsules have been reported, but no adverse events were associated with those reports.
The affected lot is GESB14011-A, with expiration 12/2015 packaged in 100-count bottles, NDC 16714-662-01. There is an imprint D on the yellow cap and 03 printed on the yellow body in black ink. The drugs were distributed via Northstar label to retail outlets nationwide.
Aurobindo warns that empty capsules may result in missed doses of gabapentin which may cause adverse health conditions including a short term reduction in efficacy, short term withdrawal effect, or status epilepticus. The company is notifying distributors and customers through recall letters and is arranging for all of the recalled product to be returned.
Customers, distributors, and retailers are advised to stop using, distributing, or dispensing the affected lot and to return it to its place of purchase.
For more information, see the FDA press release.