Breckenridge Pharmaceutical, Inc recalls Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single -
Recalled March 4, 2020 · FDA recall D-1063-2020 · Breckenridge Pharmaceutical
Hazard
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing. · FDA Class III
Units
900 Vials
Sold at
Nationwide in the U.S.
Description
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
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.
Manufacturer(s)
Breckenridge Pharmaceutical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →