Aurobindo Pharma Limited’s US subsidiary has initiated a voluntary recall of Gabapentin capsules of a particular lot in the US market as it was found to have contained some empty capsules.
The empty capsules of Gabapentin drug — used in the treatment of epilepsy — could result in the missed doses resulting in adverse health consequences that could range from no effect and short- term reduction in the efficiency, the US Food and Drug Administration(US FDA) said.
The company had received US FDA’s approval to manufacture and market the product in October, 2011.
“The affected Gabapentin lot is GESB14011-A, expiration December, 2015 and is packaged in 100-count bottles,” a statement available on the FDA website said.
The subsidiary, Aurobindo Pharma USA, is notifying distributors and customers by recall letters and arranging for its return. A company spokesman said this would not have any major financial impact.
