Sun Pharma faces another massive drug recall
Mumbai-based Sun Pharmaceutical Industries, Ltd. announced a recall for more than 428,000 bottles of generic medications, including venlafaxine, an antidepressant, and cetirizine, an antihistamine.
This follows a March 2014 recall of a batch of generic Glumetza, for the treatment of diabetes and an April 2014 recall of more than 2,500 bottles of generic metformin, also a diabetes drug.
The recalls were based on the potential for adverse events.
With three recalls in three months, Sun Pharmaceutical Industries, Ltd. is only the latest example of what is emerging as a major quality-control problem among drug makers in India. Sun is attempting to downplay the latest recall by classifying it as a class II recall, meaning the mistakes could only lead to “reversible” adverse events. Examples of quality-control problems include drug mix-ups, dosage mistakes, human hairs on pills, and in the latest case at Sun, failure of medicine to dissolve properly.
Dr. Margaret Hamburg, the commissioner of the U.S. Food and Drug Administration, visited India in February to express her concerns about pharmaceutical quality. After her trip, she wrote, “As I explained, quality is linked to product safety and without a direct focus on quality, the potential for patient harm increases significantly.” At this point, look for increased vigilance from FDA, with intense focus on quality control in India.