Some capsules may be empty
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Aurobindo Pharma USA of Dayton, N.J., is recalling lot GESB14011-A of Gabapentin capsules.
The product lot has been 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.
There have been no reports of adverse events related to this recall to date, although there have been 4 complaints of empty capsules.
Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles).
The affected Gabapentin lot, GESB14011-A, Expiration 12/2015, is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. It was distributed through the Northstar label to retail outlets nationwide.
Aurobindo Pharma USA, Inc. is notifying its distributors and customers by recall letters and is arranging for return of all recalled product.
Consumers, distributors and retailers who have the recalled product should stop using, distributing or dispensing it and return it to place of purchase.
Consumers with questions regarding this recall may contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2 or by email at PVG@aurobindousa.com Monday through Friday, 8:30AM to 5:00PM EST.
