Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.
Recalled April 6, 2016 · FDA recall D-0784-2016 · Dr. Reddy's Laboratories
Hazard
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial · FDA Class II
Units
3,342 vials
Sold at
Nationwide
Description
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Product
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →