Dr. Reddy's Laboratories ($RDY), already dealing with a host of issues tied to a warning letter for three of its Indian plants, is now being bedeviled by a recall of meds made at one of its other facilities.
According to the most recent FDA Enforcement Report, Dr. Reddy's is recalling 24,661 bottles of paricalcitol capsules manufactured at its plant in Bachupally. The paricalcitol, used in treatment of patients on dialysis, was voluntarily recalled after the drugmaker received complaints of breakage and leakage.
Last year, the Indian drugmaker recalled some lots of divalproex sodium ER, as well as the combo drug amlodipine besylate and atorvastatin, made at the Bachupally plant. In 2014, metoprolol succinate extended-release tablets produced there had to be recalled.
Also last year, Dr. Reddy's active ingredient plants in Srikakulam and Miryalaguda, as well as its Oncology Formulation manufacturing facility at Duvvada, were named in an FDA warning letter. While inspectors cited any number of data integrity and other issues at the plants, most concerning was the discovery that for years the company had what the FDA termed an "uncontrolled Custom QC laboratory" at its plant in Srikakulam. Inspectors discovered records in the lab that indicated Dr. Reddy's had repeatedly tested APIs for impurities, never recording failed tests, and then gave the agency results that indicated batches had passed tests.