Product: Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
Reason for recall: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
Recall initiated: 20200224
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated