Sun Pharmaceutical Industries Ltd, an India-based drug manufacturer, is voluntarily recalling more than 40,000 bottles of a common antidepressant after it failed to meet dissolution standards.
Venlafaxine hydrochloride, more commonly known as Effexor, is used to treat adults suffering from major depressive disorder, social phobias and general anxiety and panic disorders. Like most antidepressants, Effexor works by increasing concentrations of serotonin and norepinephrine in the brain.
When a drug undergoes performance testing, dissolution standards help inspectors determine how effective it will be in the body. Drugs that fail dissolution tests could dissolve too slowly to be effective, or too quickly, overwhelming the patient’s system.
Sun Pharmaceutical voluntarily issued the recall in June. The Food and Drug Administration (FDA) classified the preventative measure as a Class II recall, meaning that the drug’s defects could cause temporary or medically reversible health problems.
The Indian drug manufacturer has suffered several setbacks this year. Sun Pharmaceutical has already recalled several drugs: a popular chemotherapy drug, gemcitabine, was recalled over questions about sterility, and diabetes drug metformin was recalled after some bottles were improperly labeled.
The FDA has been cracking down on drug manufacturers in India after several of their factories were caught altering test results to approve defective drugs. While these companies are operating in another country, they still have to meet FDA standards to be distributed in America.
Drug Injury Lawyers in South Carolina
American companies own a large percentage of foreign drug manufacturers. Despite the distance, companies are still liable for the actions of their subsidiaries. If you were injured by a defective drug, call Proffitt & Cox to speak with one of our licensed attorneys. We specialize in pharmaceutical litigation and have a proven record defending drug injury victims. Schedule your free consultation today.
[Did You Know: In March, the US banned imports from a division of Sun Pharmaceutical for failing to practice “good manufacturing practices”.]
Proffitt & Cox, LLP – Columbia Injury Lawyer