Product: 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
Reason for recall: Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Recall initiated: 20180912
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated