Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
Recall Number: D-0103-2019
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class III
Status: Terminated
Report Date: 20181003
Initiation Date: 20180912
Termination Date: 20200303
Reason for Recall
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Product Description
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52