Another GMP issue has landed in Sun Pharma's inbox. The latest setback sees the Indian drugmaker forced to recall almost 3,300 bottles of its antiepileptic drug levetiracetam from the U.S. after the batches failed a 6-month dissolution test.
The timing of the recall means Sun and its subsidiary Taro Pharmaceuticals are currently in the middle of recalling nearly 40,000 bottles from the U.S. supply chain. Taro's recall of almost 37,000 bottles of grape-flavored loratadine syrup accounts for the bulk of the withdrawal, but Sun's actions put another black mark against its plant in Halol, India. The facility was the source of the more than 250,000 bottles of the antidepressant venlafaxine that Sun recalled last year.
Each of the three venlafaxine recalls and the levetiracetam withdrawal relate to failed dissolution tests, the causes of which FDA probed during an inspection of the Halol plant in September. The batches of levetiracetam that failed the 6-month dissolution test were manufactured before the inspection. Sun Pharma's ability to fix the source of the problem will have a significant effect on its future, particularly in the U.S., which is a major market for the Halol facility.
The company declined to comment to The Economic Times about the latest recall, but after the last venlafaxine withdrawal in November said it was working to address observations made about the plant in Halol. Work to improve Halol is proceeding in parallel to preparations for the integration of Ranbaxy Labs. Sun Pharma bought its rival in the belief that it can help it overcome its laundry list of problems with FDA.
- read the Economic Times article