Aurobindo Pharma USA Recalls One Lot of Gabapentin Capsules

November 26, 2014
Pharmaceutical Technology Editors

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. 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. Aurobindo Pharma USA has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules, the company said in a press release.

Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on the yellow cap and 03 on the yellow body with black edible ink. The product was distributed through the Northstar label to retail outlets nationwide.

Aurobindo Pharma USAis 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 it to place of purchase.

Source: FDA