India-based Aurobindo has been repeatedly knocked by the FDA for its role in global “sartan” recalls for allowing tainted active pharmaceutical ingredients (APIs) into its drugs. Now, a mislabeling snafu is pulling even more of the drugmaker’s generics off U.S. shelves.
An American subsidiary of Aurobindo voluntarily recalled 2,352 bottles—each containing about 1,000 tablets—of generic statins after certain lots were found to have incorrect or missing labels and sometimes missing expiration dates, according to an FDA Enforcement Report.
Aurolife initiated the recall in late July after the product was distributed nationwide, the FDA said. Aurobindo, with 25 manufacturing plants globally, is one of the largest generic drug manufacturers in the world and the second-largest generics producer for the U.S.
The most recent recall is unrelated to Aurobindo pulling 80 lots of valsartan off U.S. shelves in February as part of a global FDA recall of “sartan” products linked to potentially carcinogenic APIs produced by Chinese and Indian manufacturers. The recalls from a variety of producers have resulted in shortages in the U.S. of losartan.
