India's Dr. Reddy's Laboratories ($RDY) just last month had to recall nearly 25,000 bottles of a dialysis drug after getting a host of customer complaints of container leaks. Now, it is recalling a bone drug, but in this case the product was manufactured by a compatriot.
According to the most recent FDA Enforcement Report, Dr. Reddy's is recalling 3,342 vials of injectable zoledronic acid over questions of sterility after some were found to have defective seals. The med was produced by Gland Pharma, the report said.
Gland is an Indian drugmaker that specializes in injectable drugs. In late 2013, Gland got a $200 million cash infusion from New York-based private equity firm KKR. At the time, Gland founder Ravi Penmetsa said the drugmaker would invest the money to double its manufacturing capacity targeted at the U.S.
While this manufacturing misstep is Gland's, the recall comes at a bad time for Dr. Reddy's, which is already dealing with issues at three manufacturing plants the FDA cited last year in a warning letter. Dr. Reddy's active ingredient plants in Srikakulam and Miryalaguda, as well as its Oncology Formulation manufacturing facility at Duvvada, were named in the citation. The agency was particularly ticked off by the discovery that for years the company had what the FDA termed an "uncontrolled Custom QC laboratory" at its plant in Srikakulam.
- access the report here