This is the second time Sun Pharmaceuticals has recalled Effexor for this problem this year. In July, the FDA issued a Class II recall for about 41,000 bottles of Effexor because they failed to dissolve properly.
In both cases, the products were manufactured in Halol in the western state of Gujarat, India.
The FDA has already banned imports from a Sun Pharmaceuticals plant in Karkhadi in Gujarat.
The agency has also banned imports from all of the Indian plants of Ranbaxy Laboratories. Wokhardt Ltd. has also been banned from exporting drugs from some of its plants into the United States.
Sun Pharmaceuticals was inspected by the FDA in September and received a warning for having “no formalized corrective action plan” to prevent future recalls, according to the WSJ. However, the company said it has initiated “several corrective steps” and analysts say the problems are unlikely to result in an export ban.
In March, certain lots of brand-name and generic Effexor in 30-count and 90-count bottles were recalled by Pfizer after a physician reported that one bottle contained a capsule of Tikosyn, an anti-arrhythmic drug that can have serious cardiovascular side effects. Click here to read more.