Empty capsules lead to Aurobindo drug recall

Drug recalls in the US market by Indian pharma companies continue despite an increasing number of domestic companies trying to tackle regulatory challenges with the US drug regulator.

Since January, a number of Indian companies including Sun Pharmaceutical Industries, Ranbaxy Laboratories, Dr. Reddy's Laboratories, Lupin, Glenmark, Wockhardt, Cadila Healthcare have recalled a number of drugs in the US. Hyderabad-based Aurobindo Pharma is the recent addition to the list.

According to the US Food and Drug Administration (FDA), Aurobindo's US subsidiary Aurobindo Pharma USA has initiated a voluntarily recall of a batch of gabapentin capsules as some of the capsules were found empty. The drug is used in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles).

In a filing to US FDA, Aurobindo Pharma USA said, "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."

The company, however, said it has not received any reports of adverse events related to this recall, but has received four complaints for empty capsules.

The expiry date of the affected lot is December 2015 and is packaged in 100-count bottles. The product was distributed through Northstar label to retail outlets nationwide. The company received the US drug regulator's approval to manufacture and market the product in October 2011.

"Aurobindo Pharma USA 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," a release on the FDA website said.

According to an Aurobindo spokesperson, the recall has been voluntarily initiated and it will not have any financial impact on the company. Meanwhile, the pharma company on Tuesday informed the stock exchange BSE that its board has approved to raise funds through issue of securities up to an amount of $350 million (around Rs 2,166 crore) via follow-on offer, qualified institutions placements, further public offer or private placement or by such other method subject to approval of the shareholders.

In another case, Bangalore based Micro Labs' US subsidiary has also initiated recalls of antidiabetic drug glimepiride and cholesterol-lowering drug simvastatin tablets. In separate updates on FDA website, it said that Micro Labs USA, Inc. has initiated recall of 11,328 bottles of glimepiride tablets, USP 2 mg in 100-count and 500-count bottles. The drug was manufactured in the company's Goa facility and the reason for recall was given as out of specification results during stability testing. The recall (Class II type) was initiated in October 2014.

In another update, Micro Labs recalled 1,008 bottles of simvastatin tablets, USP 10 mg, 90-count bottles due to product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification. The product was manufactured at the Goa facility and the recall (Class III) was initiated in August 2014.

According to a pharma analysts, there is nothing unusual to product recalls. "Even a lot of multinationals do that. But it is important is to see that the frequency of products recall may not be too often and not from the same facility again and again. Otherwise, it could lead to a trigger for FDA."