Most drugs are recalled because of questions over the quality of a drug. India's Aurobindo has recalled a lot of an epilepsy drug because some of the capsules contain no drug at all.
The company is voluntarily recalling one lot of 300-mg 100-count bottles of gabapentin capsules, a drug used to treat the pain from shingles but also epilepsy. The bottles carry a Northstar label and were distributed to retail outlets throughout the U.S., Aurobindo said in release distributed by the FDA.
The recall was undertaken after Aurobindo received four complaints about the problem. The company said there have been no adverse reactions reported, but points out the potential that patients could have life-threatening seizures if they are not getting the prescribed dose of their drug.
Canadian generics maker Apotex faced this problem several years ago and voluntarily recalled one lot of Apo-Ramipril 5 mg capsules for high blood pressure when some were found empty. Because the capsules were not transparent, patients could not tell they contained no drug.
Aurobindo has not had any other noted recalls in the last year, but it has faced quality issues before. The FDA in 2011 issued warning letters and an import alert on products produced at two of the company's plants in Hyderabad over contamination problems. The ban on nonsterile products was lifted last year.
- here's the recall notice