November 18, 2014 — For the second time this year, Sun Pharmaceuticals has recalled Effexor (venlafaxine) because the pills may not dissolve properly.
About 68,000 bottles are subject to recall, according to the Wall Street Journal. They were manufactured in Halol in the western state of Gujarat, India, where Sun Pharmaceuticals operates three facilities.
This same facility manufactured 41,000 bottles of Effexor that were recalled in July because they failed to dissolve properly during quality-control tests.
Two months ago, FDA inspectors issued a warning to Sun Pharmaceuticals for having “no formalized corrective action plan” to prevent future recalls. One facility, located in Karkhadi, Gujarat, has already been hit with an export ban by the FDA. Sun Pharmaceuticals told the WSJ they have initiated “several corrective steps.”
The FDA has recently cracked down on generic pharmaceuticals made in India. They have already banned all imports from the Indian plants of Ranbaxy Laboratories. Similarly, several Indian plants for Wokhardt Ltd. have been banned from importing drugs into the United States.
This is at least the third recall of Effexor this year. In March, Pfizer recalled certain lots of Effexor after receiving a report from a physician who found one capsule of Tikosyn in a new bottle of Effexor. Tikosyn is prescribed to people with irregular heart-rhythm, and side effects in healthy people could include serious cardiovascular problems. Click here to read more.
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