Dayton, NJ, 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, Inc. 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 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 yellow cap and 03 on yellow body with black edible ink. Product was distributed through 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 that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase.
Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2 or PVG@aurobindousa.com Monday through Friday, 8:30AM to 5:00PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.