A Sun Pharmaceutical plant that has been a problem for the FDA, and so for the Indian drugmaker, is again having to recall a product that the company said failed dissolution testing.
According to the most recent FDA Enforcement report, Sun is voluntarily recalling three lots of bupropion hydrochloride extended-release tablets that were manufactured at its plant in Halol, in Gujarat, India. The drugmaker says that the med failed dissolution testing at 18 months because its drug-release results were not on the mark at the 4-hour time point. It is recalling 35,235 bottles of its generic of the antidepressant Wellbutrin XL
Last month, Sun blamed a 4% slide in U.S. sales for its last quarter, in large part, on "temporary supply constraints arising from remediation efforts at the Halol facility." The remediation began after the FDA issued a Form 483 to the plant upon completion of an inspection there a year ago, and the supply constraints can be tracked in part to the recalls the Indian drugmaker has had to make of meds made at the facility.
This is the latest in a string of recalls from Sun's Halol facility. Last year it retrieved 26,530 bottles of venlafaxine hydrochloride extended-release tablets, a generic of Pfizer's ($PFE) Effexor XR, after it found that the tablets did not dissolve properly. Before that, it recalled more than a quarter of a million bottles of venlafaxine as well as 128,363 bottles of the decongestant cetirizine for the same reason.
Of course the work at the Halol plant is just one piece of an extensive remediation effort by Sun as it also works to bring back to FDA standards four other Indian plants that it got this year in its $4 billion buyout of Ranbaxy Laboratories. Those four plants have been sidelined from selling in the U.S. for years after the FDA found extensive problems with each.