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

Recall Number: D-0784-2016

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20160406

Initiation Date: 20160303

Termination Date: 20170503

Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

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