Aurobindo Pharma Ltd. is voluntarily recalling 2,352 bottles of statin tablets due to incorrect labeling, the U.S. Food and Drug Administration said in an enforcement report.
The simvastatin tablets, recalled beginning July 29 after they were labeled with the incorrect lot number, treat high cholesterol and triglyceride levels. The product had already been distributed across the U.S. by three major distributors, according to the report.
The statin drug recall is the latest in a string of Aurobindo's product issues.
Aurobindo previously recalled 80 lots of a separate class of drugs as part of an industrywide recall of the high blood pressure medicines containing sartan, found to be contaminated with cancer-causing impurities.
India-based Aurobindo also faced the ire of the FDA when inspections of its Indian manufacturing facilities caused the regulatory agency to flag several manufacturing and operations concerns. The FDA said in its warning letters that Aurobindo failed to follow the appropriate manufacturing qualities required for finished drug products to meet certain standards of quality and purity.
