The most recent FDA Enforcement report states that the Mumbai, India-based Sun is voluntarily recalling three lots of bupropion hydrochloride extended-release tablets manufactured at its plant in Halol, located in Gujarat, India. According to Sun, the drug failed dissolution testing at 18 months because its drug-release results were not on the mark at the four-hour time point. The company is recalling more than 35,000 bottles of its generic of the antidepressant Wellbutrin XL.
In August, Sun blamed a 4% drop in its U.S. sales for the last quarter primarily on “temporary supply constraints arising from remediation efforts at the Halol facility.” The remediation initially began after the FDA issued a Form 483 to the plant after an inspection there last year, and the supply constraints can be connected in part to the recalls that the pharmaceutical has made of drugs produced at the facility.
Last year, Sun’s Halol plant retrieved more than 26,000 bottles of venlafaxine hydrochloride extended-release tablets, a generic of Pfizer’s Effexor XR, after it discovered that the tablets did not dissolve properly. Previously, it recalled more than 250,000 bottles of venlafaxine and more than 128,000 bottles of the decongestant cetirizine for the same reason.
The work at the Halol facility is only part of the extensive remediation work by Sun as it also attempts to bring back to FDA standards four other Indian plants that it obtained this year in its $4 billion buyout of Ranbaxy Laboratories. Those plants have been prevented from selling in the U.S. for years after the FDA found significant problems with them.