Generic Firm Commences Gabapentin Recall Due to Excessive Impurities

Ranbaxy Pharmaceuticals initiated a voluntary Class III recall of 73 million gabapentin tablets because the allowed level of impurities in the tablets exceeded their specification limits, according to FDA documents.

Gabapentin is the active ingredient in Pfizer’s antiseizure drug Neurontin, which is off patent.

The affected dosage strengths include the 600- and 800-mg tablets. Ranbaxy’s abbreviated new drug application (ANDA) for the tablet formulation is for those two strengths and the firm holds approval for a capsule formulation as well.

The company could not comment on whether the recall will create a shortage of its tablets. Sun Pharmaceutical Industries, Glenmark Pharmaceuticals, Teva Pharmaceuticals, Apotex, Sandoz and Actavis have approved ANDAs for the 600- and 800-mg dosage strengths.