India-based Sun Pharmaceutical Industries is to recall more than 40,000 bottles of an antidepressant after the drug was discovered to have problems dissolving in the body.
US regulator the FDA announced the recall of venlafaxine hydrochloride last week, stating: “Stability results found the product did not meet the drug release dissolution specifications.”
Sun now has to withdraw 26,530 bottles of 30 pills of the depression treatment and 14,597 bottles containing 90 pills.
The FDA classed the recall as class II, meaning that this is a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences. However, the probability of serious adverse health consequences is remote compared to class I.
Venlafaxine hydrochloride is part of the serotonin-norepinephrine reuptake inhibitor (SNRI) class of medicines to treat people with major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.
Sun Pharma’s product is is a generic version of Pfizer/Wyeth’s Effexor XR, which itself faced a recall earlier this year after one bottle was reported to contain a heart drug.
This is the latest in a series of setbacks for Sun Pharma in the US. During 2014 so far the company has faced a recall of chemotherapy drug gemcitabine due to sterility issues, while in January the company withdrew 2,528 bottles of its generic version of metformin.
The company has also come under criticism for its operations in India, with the FDA banning imports from a plant in Karkhadi and sending a warning letter detailing how employees deleted records of batch failures.