Gabapentin Capsules Recalled

Megan Brooks

Disclosures

November 24, 2014

Aurobindo Pharma USA has initiated a voluntary recall of one lot of 300-mg capsules of the antiepileptic agent gabapentin because some of the capsules have been found to be empty, the company announced. The alert was distributed through the US Food and Drug Administration (FDA) MedWatch system November 21.

Gabapentin is used to treat epilepsy and manage postherpetic neuralgia.

"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," warns a company press release posted on the FDA website.

No reports of adverse events related to the recall have been received, the statement said, but to date four complaints of empty capsules have been received.

The affected lot is GESB14011-A. The National Drug Code (NDC) is 16714-662-01. The recalled lot has an expiration date of December 2015 and is packaged in 100-count bottles.

The product was distributed through the Northstar label to retail outlets nationwide. It can be identified by the imprint D on the yellow cap and 03 on the yellow body with black edible ink.

"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," the company advises.

They are notifying distributors and customers of the recall by letter to arrange for return of the product. For questions regarding this recall, contact Aurobindo Pharma USA Pharmacovigilance group by phone, Monday through Friday, between 8:30 am and 5 pm Eastern time, at 732-839-9400 (option 2), or by email at PVG@aurobindousa.com.

To report problems with this product or other products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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